High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-10-19

Brief Summary

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Obesity is one of the biggest public health problems of the 21st century as it increases the risk of many co-morbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium. Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.

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Detailed Description

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Conditions

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DELAYED LABOUR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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low dose oxytocin

patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 2 mU/min, incrementally increase by 2 mU/min every 30 minutes until achievement of adequate uterine contractions.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

intravenous infusion

high dose oxytocin

patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 4 mU/min, incrementally increase by 4 mU/min every 30 minutes until achievement of adequate uterine contractions

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

intravenous infusion

Interventions

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Oxytocin

intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Spontaneous onset of labor.
* Body mass index ≥ 30 kg/m2.
* Gestational age ≥ 37 weeks.
* Singleton pregnancy.
* Cephalic presentation.
* Reassuring fetal heart rate monitoring.
* Inefficient uterine contractions during active labor
* Women who will accept to participate in the study.

Exclusion Criteria

* Non-reassuring fetal assessment at the time of recruitment.
* Women received cervical ripening agents.
* Any patients contraindicated for vaginal delivery.
* Multiple gestations.
* Malpresentation.
* Previous cesarean delivery.
* Patients with cardiac diseases, pre-eclampsia or any other medical disorders.
* Fetal demise.
* Intrauterine growth restriction.
* Estimated fetal weight ≥ 5000 grams.
* Pre-labor rupture of membranes \> 24 hours.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No