Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term

NCT ID: NCT02581774

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Oligohydramnios

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

term isolated oligohydramnios

Labor Monitoring and normal delivery tracking

normal delivery tracking

Intervention Type: OTHER

normal delivery tracking

prolonged pregnancies

Labor Monitoring and normal delivery tracking

normal delivery tracking

Intervention Type: OTHER

normal delivery tracking

Interventions

normal delivery tracking

normal delivery tracking

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nazlı YENIGUL

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

304

Identifier Type: -

Identifier Source: org_study_id