Clinical trial NCT02581774: Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term
Official title: Management of Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term; the Mode of Delivery and the Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oligohydramnios
Keywords: induction
cesarean delivery
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean rates in pregnancies complicated with isolated oligohydramnios
timeFrame: up to 18 month
Secondary outcomes:
measure: Fetal distress rates
timeFrame: up to 18 month
measure: Number of patients (fetus) with 5-min Apgar score < 7
timeFrame: up to 18 month
measure: Number of patients with meconium stained amniotic fluid
timeFrame: up to 18 month
Other outcomes:
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