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

NCT ID: NCT01773135

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 262 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-01-31

Brief Summary

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

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.

Conditions

Threatened Preterm Labor

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

collection of blood sample and tocolysis adminstration

Intervention Type: OTHER

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)

collection of blood sample and tocolysis adminstration

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Saied Eldein El-Safty

Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed S. Elsafty, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ainshams Maternity hospital

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

MAI-01110333535m

Identifier Type: REGISTRY

Identifier Source: secondary_id

mai-01110333535

Identifier Type: -

Identifier Source: org_study_id