Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02581774

Collaborator

(none)

324

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oligohydramnios	Other: normal delivery tracking

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 Design

Study Type:

Observational

Actual Enrollment :

324 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Cesarean rates in pregnancies complicated with isolated oligohydramnios [up to 18 month]

Secondary Outcome Measures

Fetal distress rates [up to 18 month]
Number of patients (fetus) with 5-min Apgar score < 7 [up to 18 month]
Number of patients with meconium stained amniotic fluid [up to 18 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nazlı YENIGUL, MD, Sisli Hamidiye Etfal Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT02581774

Other Study ID Numbers:

First Posted:

Oct 21, 2015

Last Update Posted:

Oct 21, 2015

Last Verified:

Jan 1, 2013

Keywords provided by Nazlı YENIGUL, MD, Sisli Hamidiye Etfal Training and Research Hospital

induction

cesarean delivery

Additional relevant MeSH terms:

Oligohydramnios

Study Results

No Results Posted as of Oct 21, 2015