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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed Saied Eldein El-Safty, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT01773135
First received: January 15, 2013
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Threatened Preterm Labor
Other: collection of blood sample and tocolysis adminstration

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 9 Weeks
Official Title: Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor

Further study details as provided by Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    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


Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 262
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   17 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01773135

Locations
Egypt
Ainshams Maternity hospital
Cairo, Egypt, 133119
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Principal Investigator: Mohamed S. Elsafty, M.D. Ain Shams University
  More Information

No publications 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     History of Changes
Other Study ID Numbers: mai-01110333535, MAI-01110333535m
Study First Received: January 15, 2013
Results First Received: February 21, 2014
Last Updated: February 21, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams Maternity Hospital:
threatened preterm labor
ACTH
PTL

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014