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Completed

NCT Number: NCT02581774

Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

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.

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Key information

Conditions

Oligohydramnios Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal delivery tracking

Other

normal delivery tracking

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

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2015
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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