Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

Sponsor

Mohamed Sayed Abdelhafez (Other)

Overall Status

Unknown status

CT.gov ID

NCT02673359

Collaborator

(none)

220

Enrollment

Locations

Arms

40.9

Duration (Months)

73.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.

Condition or Disease	Intervention/Treatment	Phase
Premature Labour	Drug: Progesterone Procedure: Cervical cerclage	Phase 4

Detailed Description

Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Progesterone group Vaginal progesterone suppositories will be given	Drug: Progesterone Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day Other Names: Cyclogest Prontogest
Active Comparator: Cerclage group Cervical cerclage will be performed.	Procedure: Cervical cerclage Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage) Other Names: Cervical stitch

Arm

Intervention/Treatment

Active Comparator: Progesterone group

Vaginal progesterone suppositories will be given

Drug: Progesterone

Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day

Other Names:

Cyclogest

Prontogest

Active Comparator: Cerclage group

Cervical cerclage will be performed.

Procedure: Cervical cerclage

Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)

Other Names:

Cervical stitch

Outcome Measures

Primary Outcome Measures

Preterm labor before 35 weeks [Up to 35 weeks gestational age]

Secondary Outcome Measures

Delivery before 37 weeks [Up to 37 weeks gestational age]
Low birth weight (LBW) [At birth]
Birth weight of a living neonate of < 2500 gm regardless of gestational age
Neonatal respiratory distress syndrome (RDS) [At birth]
Early neonatal death (END) [One month after birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with singleton pregnancy.
History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.

Exclusion Criteria:

Age < 20 or > 35 years.
Congenital uterine malformation.
Multifetal pregnancy.
Known major fetal structural or chromosomal abnormality.
Known allergy or contraindication (relative or absolute) to progesterone therapy.
Presence of contraindication to cervical cerclage.
Medical conditions complicating pregnancy.
Vaginal bleeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Dakahlia	Egypt	35111
2	Private practice settings	Mansourah	Dakahlia	Egypt
3	Obstetrics and Gynecology Department in Port Said University	Port Said		Egypt