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

NCT06990217 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 0022-24-EMC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Induction of Labor; Augmentation of Labor

Keywords

induction of labor; augmentation of labor; obese; obese gravida; high dose of oxytocin in obese gravida

Outcome Measures

Primary Outcomes (1)

• Time from the start of oxytocin to delivery

  our hypothesis that high dose of oxytocin shortens the time from the start of induction to delivery

  from the start of induction till delivery

Secondary Outcomes (14)

• Maternal age

  at enrollment

• mode of delivery

  at delivery

• intrapartum fever

  during labor

• uterine rupture

  up to 6 weeks after delivery

• perineal tears

  during delivery

Study Arms (2)

High dose oxytocin

ACTIVE COMPARATOR

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.

Drug: Oxytocin Grindeks 10 IU/ml- solution for injection

Low dose oxytocin

OTHER

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.

Drug: Oxytocin Grindeks 10 IU/ml- solution for injection

Interventions

Oxytocin Grindeks 10 IU/ml- solution for injection DRUG

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

High dose oxytocin; Low dose oxytocin

Eligibility Criteria

• Gender Eligibility Details: only female gravida
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women with previous cesarean delivery
• Multiple pregnancy
• Multiple fetal malformations
• IUFD

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Obesity

Interventions

Solutions; Injections

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Rula Iskander, MD

  Emek Medical Center

  STUDY CHAIR

Central Study Contacts

Rula Iskander, MD

CONTACT

+972544357554; rula_isk@hotmail.com

Galit Garmi

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Rula Iskander - ObGyn resident and official investigator

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

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)