Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-12-31

Brief Summary

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The goal of this clinical trial is to compare between higher and lower dose of oxytocin to induce delivery in obese women. Researches will compare between low and high doses of oxytocin. the study group will use high dose of oxytocin (20 units in 1000 ml) versus the control group which will use low dose of oxytocin (10 units of oxytocin in 1000 ml)

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Detailed Description

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the duration and the progression of the first stage of labor is slower in obese women and oxytocin seems to be less effective in the treatment of protracted labor in obese women. There is no consensus in the literature about the optimal oxytocin dose. Hence, the objective of this study is to compare 2 oxytocin regimens, low VS high dose among obese women who need induction or augmentation of labor.

Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor. Who are obese (BMI 30 and above), Viable singleton pregnancies with Cephalic presentation. After their consent, will be randomization: in a 1:1 allocation.

Group 1 (control) will receive a low dose- 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.

Group 2 (study) will receive a high dose- 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.

The primary outcome of the study is the time from the start of oxytocin to delivery

Statistical analysis Mean time interval from initiation of augmentation/ induction with oxytocin until delivery was eight hours (±240 minutes), based on previous observation at the delivery ward. The aim of study is to demonstrate a difference of 2 hours between the 2 groups with an alpha of 0.05 and a power of 80%, a sample size of 64 women per group is required. The primary analysis will be performed on the groups as allocated, that is, by the intention to treat, including all women as randomized.

Conditions

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Induction of Labor Augmentation of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the two study groups will get the same drug but different dosage.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High dose oxytocin

This arm of the study will receive high dose oxytocin - 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.

Group Type ACTIVE_COMPARATOR

Oxytocin Grindeks 10 IU/ml- solution for injection

Intervention Type DRUG

our study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor

Low dose oxytocin

This arm of the study will receive low dose oxytocin- - 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.

Group Type OTHER

Oxytocin Grindeks 10 IU/ml- solution for injection

Intervention Type DRUG

our study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor

Interventions

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Oxytocin Grindeks 10 IU/ml- solution for injection

our study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor.
* BMI 30 and above
* Viable singleton pregnancies
* Cephalic presentation.
* No contraindication for vaginal delivery