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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

Short name PTL

NCTNCT01773135 (opens ClinicalTrials.gov in a new tab)Other idmai-01110333535Other idMAI-01110333535m
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
262 participants (actual)
Sponsor
Ain Shams Maternity Hospital · Other
Design
Not stated
Countries
1 country

Egypt

Start
Jan 2013
Primary completion
Oct 2013
Completion
Jan 2014
First posted
23 Jan 2013 (estimated)
Last update posted
3 Apr 2014 (estimated)
Conditions
Threatened Preterm Labor

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph –

    PTL

    NCT01773135

    Jan 2013 to Jan 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • collection of blood sample and tocolysis adminstrationOther

Arms2

  • Other

    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

    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)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor

    Time frame · 9 weeks

    Registry 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 9 weeks

Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor

GroupValue (pg/ml)
Preterm Group23.4
Full Term Group19.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pregnant Women With Threatened Preterm Laborpregnant 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.–0 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 17 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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