Clinical trial NCT06990217: Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor
Official title: Comparison of Oxytocin Dosing Regimen' Low Versus High, in Gravida Women With BMI 30 and Above Undergoing Induction of Labor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Induction of Labor
Augmentation of Labor
Keywords: induction of labor
augmentation of labor
obese
obese gravida
high dose of oxytocin in obese gravida
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 130
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the two study groups will get the same drug but different dosage.
Primary purpose: TREATMENT

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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from the start of oxytocin to delivery
timeFrame: from the start of induction till delivery
Secondary outcomes:
measure: Maternal age
timeFrame: at enrollment
measure: mode of delivery
timeFrame: at delivery
measure: intrapartum fever
timeFrame: during labor
measure: uterine rupture
timeFrame: up to 6 weeks after delivery
measure: perineal tears
timeFrame: during delivery
measure: PPH
timeFrame: up to 6 weeks
measure: length of postpartum stay
timeFrame: perinatal.
measure: Maternal satisfaction
timeFrame: will be assessed up to 1 day after delivery
measure: Neonatal outcomes
timeFrame: up to 1 week
measure: Neonatal outcomes
timeFrame: up to 1 week
measure: Apgar score
timeFrame: at 1, 5 and 10 minutes
measure: GTPAL system
timeFrame: at enrollment
measure: maternal weight
timeFrame: at enrollment
measure: maternal height
timeFrame: at enrollment
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: Emek Medical Center
name: Rula Iskander, MD
role: STUDY_CHAIR
References: