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Clinical Trial Summary

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


Clinical Trial 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

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT01773135
Study type Observational [Patient Registry]
Source Ain Shams Maternity Hospital
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date January 2014

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04878978 - Premature Rupture Membranes and tPTL: a Personalised Approach (PROMPT) N/A
Recruiting NCT06157203 - Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
Recruiting NCT05343806 - Nifedipine Versus Magnesium Sulfate for Late Preterm Tocolysis N/A
Withdrawn NCT01314859 - Nifedipine Treatment in Preterm Labor Phase 3
Recruiting NCT05477381 - Cervical Softening and the Prediction of Preterm Birth
Recruiting NCT04374916 - Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor N/A
Recruiting NCT05345132 - Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs N/A