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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHaEmek Medical Center, Israel

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Women with previous cesarean delivery

Multiple pregnancy

Multiple fetal malformations

IUFD

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: High dose oxytocinActive comparator 1 intervention
Group B: Low dose oxytocinOther 1 intervention

Trial outcomes

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

Time frame
from the start of induction till delivery

Secondary outcomes

1

Maternal age

maternal age at enrollment

Time frame
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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: