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CompletedNCT02581774Updated Oct 21, 2015

Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

An observational study in Oligohydramnios, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-21.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
324
Ages
18 Years to 44 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Oligohydramnios

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Keywords

  • induction
  • cesarean delivery
03

In context

Oligohydramnios

25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.

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Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 114 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • women with presence of any chronic disease
  • maternal condition complicating the pregnancy
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
324 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othernormal delivery tracking

    normal delivery tracking

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What researchers measure

Primary outcomes

  1. Cesarean rates in pregnancies complicated with isolated oligohydramnios

    Time frame: up to 18 month

Secondary outcomes

  1. Fetal distress rates

    Time frame: up to 18 month

  2. Number of patients (fetus) with 5-min Apgar score < 7

    Time frame: up to 18 month

  3. Number of patients with meconium stained amniotic fluid

    Time frame: up to 18 month

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Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2015
First posted
Oct 21, 2015
Start
Jan 2013
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Last update
Oct 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02581774
Responsible party
Nazlı YENIGUL (MD, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Oct 21, 2015
Start date
Jan 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Oct 21, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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