Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

October 19, 2015 updated by: Nazlı YENIGUL, Sisli Hamidiye Etfal Training and Research Hospital

Management of Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term; the Mode of Delivery and the Neonatal Outcomes

The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies complicated with isolated oligohydramnios managed by induction of labor. This prospective case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women with postdate pregnancies who met the inclusion criteria underwent induction of labor with dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared between two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed as a prospective study. The rates of cesarean section and maternal/fetal outcomes had been compared between pregnancies complicated with isolated oligohydramnios at term and postdate pregnancies. All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound. All patients who accepted to join the study gave informed consent. All patients had a complete physical and obstetrical examination. Vital signs were recorded at regular intervals. The primary outcome measure was defined as cesarean section rates in pregnancies complicated with isolated oligohydramnios managed by induction of labor.

Study Type

Observational

Enrollment (Actual)

324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound.

Description

Inclusion Criteria:

  • term isolated oligohydramnios
  • postdate pregnancies
  • vertex presentation
  • singleton pregnancies
  • primigravid and multigravid women

Exclusion Criteria:

  • women with presence of any chronic disease
  • maternal condition complicating the pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
term isolated oligohydramnios
Labor Monitoring and normal delivery tracking
Other: normal delivery tracking
normal delivery tracking
prolonged pregnancies
Labor Monitoring and normal delivery tracking
Other: normal delivery tracking
normal delivery tracking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cesarean rates in pregnancies complicated with isolated oligohydramnios
Time Frame: up to 18 month
up to 18 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Fetal distress rates
Time Frame: up to 18 month
up to 18 month
Number of patients (fetus) with 5-min Apgar score < 7
Time Frame: up to 18 month
up to 18 month
Number of patients with meconium stained amniotic fluid
Time Frame: up to 18 month
up to 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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