PECEP: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

• Sponsor: Maternal-Infantil Vall d´Hebron Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00706264
• Collaborator: Hospital Universitario de Canarias (Other), Hospital Son Llatzer (Other), Institut Universitari Dexeus (Other)
• Enrollment: 385
• Locations: 6
• Arms: 2
• Duration (Months): 85
• Patients Per Site: 64.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Device: Silicon ring (Arabin Pessary)	N/A

Detailed Description

This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 385 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 Expectant management
Experimental: 2 Placement of arabin pessary since 23 weeks until 37 weeks	Device: Silicon ring (Arabin Pessary); Placement of a silicon pessary in the vagina, around the cervix.; Other Names: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

Outcome Measures

Primary Outcome Measures

1. Spontaneous Delivery Before 34 Completed Weeks [Between 24 and 34 weeks]

   Number of spontaneous preterm births before 34 weeks occurred in each group.

Secondary Outcome Measures

1. Birthweight Less Than 1500 g [Time of delivery]

   Number of newborns whose birthweight is less than 1500 grams

2. Birthweight Less Than 2500 g [Time of delivery]

   Number of newborns whose birthweight is less than 2500 grams

3. Intrauterine Fetal Demise [Pregnancy]

   The number of fetal deaths in the pessary group was compared to those in the no pessary group

4. Neonatal Death [Between birth and 28 days of age]

   The number of neonatal deaths in the pessary group was compared to those in the no pessary group

5. Intraventricular Haemorrhage [Between birth and 28 days of age]

   The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group

6. Respiratory Distress Syndrome [Between birth and 28 days of age]

   The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group

7. Retinopathy of Prematurity [Between birth and 28 days of age]

   The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group

8. Necrotising Enterocolitis [Between birth and 28 days of age]

   The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group

9. Treatment for Sepsis [Between birth and 28 days of age]

   The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group

10. Composite Adverse Outcomes [Between birth and 28 days of age]

    The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group

11. Spontaneous Delivery Before 28 Completed Weeks [Between 24 and 28 weeks]

    Number of preterm births before 28 weeks occurred in each group.

12. Any Delivery Before 34 Completed Weeks [Between 24 and 34 weeks]

    Number of all preterm births before 34 weeks occurred in each group.

13. Spontaneous Delivery Before 37 Completed Weeks [Between 24 and 37 weeks]

    Number of preterm births before 37 weeks occurred in each group.

14. Gestational Age at Delivery [At time of birth]

    Number of weeks of gestation completed by time of delivery

15. Use of Tocolysis [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants required use of tocolytic medication

16. Use of Antenatal Steroids [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants that received betamethasone to reduce morbidity of expected preterm delivery

17. Chorioamnionitis [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.

18. Vaginal Bleeding [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who experienced bleeding from lower genital tract during antepartum period

19. Preterm Premature Rupture of Membranes [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.

20. Cesarean Delivery [At time of delivery]

    Number of participants that underwent cesarean delivery

21. Vaginal Discharge [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who experienced an increased vaginal discharge.

22. Pessary Repositioning Without Removal [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).

23. Pessary Withdrawal [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Singleton pregnancy

• Minimal age of 18 years

Exclusion Criteria:

• Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)

• SROM at the time of randomization

• Cervical cerclage in situ

• Active vaginal bleeding

• Previous cone biopsy or cerclage

• Major uterine structural anomalies

• Placenta previa

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Materno-Infantil de Canarias	Las Palmas de Gran Canaria	Gran Canaria	Spain	35016
2	Hospital Son Llàtzer	Palma de Mallorca	Mallorca	Spain	07198
3	Hospital de Reus	Reus	Tarragona	Spain
4	Hospital Vall d´Hebron	Barcelona		Spain	08035
5	Institut Universitary Dexeus	Barcelona		Spain
6	Hospital de Fuenlabrada	Madrid		Spain

Sponsors and Collaborators

• Maternal-Infantil Vall d´Hebron Hospital
• Hospital Universitario de Canarias
• Hospital Son Llatzer
• Institut Universitari Dexeus

Investigators

• Study Director: ELENA CARRERAS, PhD, Maternal-Infantil Vall d´Hebron Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Goya, MD, PhD, PhD, Maternal-Infantil Vall d´Hebron Hospital
• ClinicalTrials.gov Identifier: NCT00706264
• Other Study ID Numbers: PECEP-TRIAL
• First Posted: Jun 27, 2008
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Maria Goya, MD, PhD, PhD, Maternal-Infantil Vall d´Hebron Hospital: Short cervix; preterm birth; arabin pessary
• Additional relevant MeSH terms: Premature Birth; Silicon

Study Results

Participant Flow

Recruitment Details	You are right that our fi rst planned sample size was 2780 patients. However, after the first interim analysis, and in accordance with the advice of our Data Monitoring Committee, the protocol was amended to reach the new and fi nal sample size.

Arm/Group Title	Expectant Management	Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Arm/Group Description	Expectant management: Current conventional management.	Placement of arabin pessary since 23 weeks until 37 weeks Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
Period Title: Overall Study
STARTED	193	192
COMPLETED	190	190
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Expectant Management	Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks	Total
Arm/Group Description	Both groups were seen by the clinical team of the trial at each centre every month until delivery. Transabdominal ultrasonography was done for fetal biometries and wellbeing, clinical questionnaire was administered for confi rmation of correct device placement in the pessary group (fi gure 2), vaginal swab was taken for study of bacteriological infection, and transvaginal ultra sonography was done to measure cervical length (fi gure 3)	The pessary was removed during the 37th week of gestation. Indications for pessary removal before this time were active vaginal bleeding, risk of preterm labour with persistent contractions despite tocolysis, or severe patient discomfort.	Total of all reporting groups
Overall Participants	190	190	380
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	190 100%	190 100%	380 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.6 (5.4)	30.3 (5.1)	30.1 (5.3)
Sex: Female, Male (Count of Participants)
Female	190 100%	190 100%	380 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	56 29.5%	58 30.5%	114 30%
Not Hispanic or Latino	134 70.5%	132 69.5%	266 70%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Spain	190 100%	190 100%	380 100%

Outcome Measures

1. Primary Outcome

Title	Spontaneous Delivery Before 34 Completed Weeks
Description	Number of spontaneous preterm births before 34 weeks occurred in each group.
Time Frame	Between 24 and 34 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	51 26.8%	12 6.3%

2. Secondary Outcome

Title	Birthweight Less Than 1500 g
Description	Number of newborns whose birthweight is less than 1500 grams
Time Frame	Time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	26 13.7%	9 4.7%

3. Secondary Outcome

Title	Birthweight Less Than 2500 g
Description	Number of newborns whose birthweight is less than 2500 grams
Time Frame	Time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Expectant Management	Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Arm/Group Description	Expectant management: usual management	Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
Measure Participants	190	190
Count of Participants [Participants]	56 29.5%	17 8.9%

4. Secondary Outcome

Title	Intrauterine Fetal Demise
Description	The number of fetal deaths in the pessary group was compared to those in the no pessary group
Time Frame	Pregnancy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Neonatal Death
Description	The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	1 0.5%	0 0%

6. Secondary Outcome

Title	Intraventricular Haemorrhage
Description	The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	2 1.1%	0 0%

7. Secondary Outcome

Title	Respiratory Distress Syndrome
Description	The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	23 12.1%	5 2.6%

8. Secondary Outcome

Title	Retinopathy of Prematurity
Description	The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	2 1.1%	0 0%

9. Secondary Outcome

Title	Necrotising Enterocolitis
Description	The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	2 1.1%	0 0%

10. Secondary Outcome

Title	Treatment for Sepsis
Description	The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	12 6.3%	3 1.6%

11. Secondary Outcome

Title	Composite Adverse Outcomes
Description	The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Time Frame	Between birth and 28 days of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	30 15.8%	5 2.6%

12. Secondary Outcome

Title	Spontaneous Delivery Before 28 Completed Weeks
Description	Number of preterm births before 28 weeks occurred in each group.
Time Frame	Between 24 and 28 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	16 8.4%	4 2.1%

13. Secondary Outcome

Title	Any Delivery Before 34 Completed Weeks
Description	Number of all preterm births before 34 weeks occurred in each group.
Time Frame	Between 24 and 34 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	53 27.9%	14 7.4%

14. Secondary Outcome

Title	Spontaneous Delivery Before 37 Completed Weeks
Description	Number of preterm births before 37 weeks occurred in each group.
Time Frame	Between 24 and 37 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	113 59.5%	41 21.6%

15. Secondary Outcome

Title	Gestational Age at Delivery
Description	Number of weeks of gestation completed by time of delivery
Time Frame	At time of birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Mean (Standard Deviation) [weeks]	34.9 (4.0)	37.7 (2.0)

16. Secondary Outcome

Title	Use of Tocolysis
Description	Number of participants required use of tocolytic medication
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	101 53.2%	64 33.7%

17. Secondary Outcome

Title	Use of Antenatal Steroids
Description	Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	121 63.7%	80 42.1%

18. Secondary Outcome

Title	Chorioamnionitis
Description	Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	6 3.2%	5 2.6%

19. Secondary Outcome

Title	Vaginal Bleeding
Description	Number of participants who experienced bleeding from lower genital tract during antepartum period
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	9 4.7%	7 3.7%

20. Secondary Outcome

Title	Preterm Premature Rupture of Membranes
Description	Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	17 8.9%	3 1.6%

21. Secondary Outcome

Title	Cesarean Delivery
Description	Number of participants that underwent cesarean delivery
Time Frame	At time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	40 21.1%	41 21.6%

22. Secondary Outcome

Title	Vaginal Discharge
Description	Number of participants who experienced an increased vaginal discharge.
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	190	190
Count of Participants [Participants]	87 45.8%	190 100%

23. Secondary Outcome

Title	Pessary Repositioning Without Removal
Description	Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	0	190
Count of Participants [Participants]	0 0%	27 14.2%

24. Secondary Outcome

Title	Pessary Withdrawal
Description	Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Time Frame	participants will be followed for the duration of pregnancy, up to nine months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Intervention: No Pessary	Experimental: Pessary
Arm/Group Description	No pessary will be used. Subjects will receive standard obstetrical care and management.	Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Measure Participants	0	190
Count of Participants [Participants]	0 0%	1 0.5%

Adverse Events

Time Frame	Starting at 24 weeks until 28 days after birth
Arm/Group Title	Expectant Management		Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Arm/Group Description	Expectant management: usual management		Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
All Cause Mortality
	Expectant Management		Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/190 (0%)
Serious Adverse Events
	Expectant Management		Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/190 (0%)
Other (Not Including Serious) Adverse Events
	Expectant Management		Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/190 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.