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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

NCTNCT06990217 (opens ClinicalTrials.gov in a new tab)Other id0022-24-EMC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
130 participants (estimated)
Sponsor
HaEmek Medical Center, Israel · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Israel

Start
Jun 2025 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
First posted
25 May 2025
Last update posted
25 May 2025
Conditions
Induction of Labor · Augmentation of Labor

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 4

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

    NCT06990217

    est. Jun 2025 to est. Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)

Interventions

  • Oxytocin Grindeks 10 IU/ml- solution for injectionDrug

Arms2

  • Active comparator

    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.

  • Other

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time from the start of oxytocin to delivery

    Time frame · from the start of induction till delivery

    Registry description

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

Secondary outcomes(14)

  1. Maternal age

    Time frame · at enrollment

    Registry description

    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.

    Registry description

    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

    Registry description

    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

    Registry description

    NICU admittion

  10. Neonatal outcomes

    Time frame · up to 1 week

    Registry description

    neonatal PH\<7.1

  11. Apgar score

    Time frame · at 1, 5 and 10 minutes

    Registry description

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

  12. GTPAL system

    Time frame · at enrollment

    Registry description

    GTPAL system assessed by questionnaire

  13. maternal weight

    Time frame · at enrollment

    Registry description

    weight before pregnancy, weight at admission

  14. maternal height

    Time frame · at enrollment

    Registry description

    height

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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