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NCT Number: NCT06990217

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

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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Key information

Conditions

Induction of Labor Augmentation of Labor Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Haemek Medical Center

Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Time from the start of oxytocin to delivery

    Time frame: from the start of induction till delivery

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

Secondary outcomes

  1. Maternal age

    Time frame: at enrollment

    maternal age at enrollment

  2. mode of delivery

    Time frame: at delivery

  3. intrapartum fever

    Time frame: during labor

  4. uterine rupture

    Time frame: up to 6 weeks after delivery

  5. perineal tears

    Time frame: during delivery

  6. PPH

    Time frame: up to 6 weeks

  7. length of postpartum stay

    Time frame: perinatal.

    normally a gravida's length of stay after normal delivery is 48 hours and after c-section is up to 3-4 days.

  8. Maternal satisfaction

    Time frame: will be assessed up to 1 day after delivery

    We will assess maternal satisfaction using a scale - Birth Satisfaction Scale-Revised (BSS-R). a five pont scale, 0 is totally disagree, 5 totally agree.

  9. Neonatal outcomes

    Time frame: up to 1 week

    NICU admittion

  10. Neonatal outcomes

    Time frame: up to 1 week

    neonatal PH<7.1

  11. Apgar score

    Time frame: at 1, 5 and 10 minutes

    minimum 0 and maximum 10. zero is bad outcome 10 is good outcome

  12. GTPAL system

    Time frame: at enrollment

    GTPAL system assessed by questionnaire

  13. maternal weight

    Time frame: at enrollment

    weight before pregnancy, weight at admission

  14. maternal height

    Time frame: at enrollment

    height

Study contacts

Contact information is provided by the study sponsor or research team.

Galit Garmi

CONTACT

Rula Iskander, MD

CONTACT

[email protected]

+972544357554

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Comparison of Oxytocin Dosing Regimen' Low Versus High, in Gravida Women With BMI 30 and Above Undergoing Induction of Labor

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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