Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

Oligohydramnios Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581774
• Other study ID #: 304
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2015
• Last updated: October 19, 2015
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Sisli Etfal Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oligohydramnios

Intervention

Other:
• normal delivery tracking
normal delivery tracking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Etfal Training & Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean rates in pregnancies complicated with isolated oligohydramnios		up to 18 month	No
Secondary	Fetal distress rates		up to 18 month	No
Secondary	Number of patients (fetus) with 5-min Apgar score < 7		up to 18 month	No
Secondary	Number of patients with meconium stained amniotic fluid		up to 18 month	No