PTL: Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor

• Sponsor: Ain Shams Maternity Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01773135
• Collaborator: (none)
• Enrollment: 262
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 21.8

Study Details

Study Description

Brief Summary

The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .

Condition or Disease	Intervention/Treatment	Phase
Threatened Preterm Labor	Other: collection of blood sample and tocolysis adminstration

Detailed Description

This is a cross sectional study that will include 261 pregnant women aged between 17 and 35 years with singleton pregnancies between 28 and 36 completed weeks of gestation that had been diagnosed with threatened preterm labor and consented to participate in this study. This study will be conducted at Ain Shams University Maternity Hospital after approval of the research and ethics committee.

the investigators include all patients which have these following criteria (Singleton pregnancy, Age between 17 - 35 years, Gestational age between 28 and 36 weeks and Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.

the investigators exclude any patient which has any of the following criteria (Preterm rupture of membranes, Any uterine anomalies or cervical incompetence, Chronic illness such as chronic hypertension or kidney disease, Diabetes mellitus, Abruptio placenta, Preeclampsia and HELLP syndrome, Fetal anomalies, IUGR, Smoking or Clinical signs of intrauterine infection).

blood sample was collected from each patient for measurement of ACTH level. According to local protocol in Ain Shams University Maternity Hospital all women will receive a fixed regimen of tocolysis in the form of nifedipine (Epilat) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery.

After delivery, the investigators divide the patients into 2 groups (full term delivery & preterm delivery) and we compare between these 2 groups by level of hormone.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 262 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
preterm group pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened preterm labor in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%. collection of blood sample and tocolysis administration will be done this group will deliver preterm (before 37 weeks of gestation)	Other: collection of blood sample and tocolysis adminstration; investigators will abtain a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor will receive a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery. After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone.
full term group pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened preterm labor in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%. collection of blood sample and tocolysis administration will be done this group will deliver full term (after 37 weeks of gestation)	Other: collection of blood sample and tocolysis adminstration; investigators will abtain a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor will receive a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery. After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone.

Outcome Measures

Primary Outcome Measures

1. Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor [9 weeks]

   measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Singleton pregnancy.

• Age between 17 - 35 years.

• Gestational age between 28 and 36 weeks.

• Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.

Exclusion Criteria:

• Preterm rupture of membranes.

• Any uterine anomalies or cervical incompetence.

• Chronic illness such as chronic hypertension or kidney disease.

• Diabetes mellitus.

• Abruptio placenta.

• Preeclampsia and HELLP syndrome.

• Fetal anomalies.

• IUGR.

• Smoking.

• Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ainshams Maternity hospital	Cairo		Egypt	133119

Sponsors and Collaborators

• Ain Shams Maternity Hospital

Investigators

• Principal Investigator: Mohamed S. Elsafty, M.D., Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Saied Eldein El-Safty, Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams University, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT01773135
• Other Study ID Numbers: mai-01110333535; MAI-01110333535m
• First Posted: Jan 23, 2013
• Last Update Posted: Apr 3, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Mohamed Saied Eldein El-Safty, Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams University, Ain Shams Maternity Hospital: threatened preterm labor; ACTH; PTL
• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature

Study Results

Participant Flow

Arm/Group Title	Pregnant Women With Threatened Preterm Labor
Arm/Group Description	pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%. then, collection of blood sample and tocolysis adminstration will be done investigators obtained a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery. After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone.
Period Title: Overall Study
STARTED	262
COMPLETED	262
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Preterm Group	Full Term Group	Total
Arm/Group Description	pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor. investigators obtained a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery. this group delivered preterm (before 37 weeks of gestation)	pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor. investigators obtained a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery. this group delivered full term (after 37 weeks of gestation)	Total of all reporting groups
Overall Participants	161	101	262
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	26	26	26
Sex: Female, Male (Count of Participants)
Female	161 100%	101 100%	262 100%
Male	0 0%	0 0%	0 0%
gestational age at admission (weeks) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [weeks]	31	31	31

Outcome Measures

1. Primary Outcome

Title	Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor
Description	measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preterm Group	Full Term Group
Arm/Group Description	group of patients who delivered before 37 weeks of gestation	group of patients who delivered after 37 weeks of gestation
Measure Participants	161	101
Median (Inter-Quartile Range) [pg/ml]	23.4	19.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preterm Group, Full Term Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	U statistic
	Comments

Adverse Events

Arm/Group Title	Pregnant Women With Threatened Preterm Labor
Arm/Group Description	pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%. then, collection of blood sample and tocolysis adminstration will be done investigators obtained a blood sample from all patient to measure the serum level of ACTH. all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery. After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone.
All Cause Mortality
	Pregnant Women With Threatened Preterm Labor
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pregnant Women With Threatened Preterm Labor
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Pregnant Women With Threatened Preterm Labor
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

It's the different time of day that blood sampling was carried out, although this reflects normal clinical practice, blood samples were collected at the time of admission to hospital regardless of the time of day, rather than diurnal pattern of ACTH.

More Information

Certain Agreements

All Principal Investigators ARE 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.