NCT02581774

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
Last Updated

October 21, 2015

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

October 13, 2015

Last Update Submit

October 19, 2015

Conditions

Keywords

inductioncesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Cesarean rates in pregnancies complicated with isolated oligohydramnios

    up to 18 month

Secondary Outcomes (3)

  • 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

Study Arms (2)

term isolated oligohydramnios

Labor Monitoring and normal delivery tracking

Other: normal delivery tracking

prolonged pregnancies

Labor Monitoring and normal delivery tracking

Other: normal delivery tracking

Interventions

normal delivery tracking

prolonged pregnanciesterm isolated oligohydramnios

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Oligohydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 21, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 21, 2015

Record last verified: 2013-01