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

HaEmek Medical Center, Israel

Status and phase: Not yet enrolling; Phase 4

Conditions: Augmentation of Labor; Induction of Labor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06990217

0022-24-EMC

Details and patient eligibility

About

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)

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

High dose oxytocin

Active Comparator group

Description:

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.

Treatment:

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

Low dose oxytocin

Other group

Description:

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.

Treatment:

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