Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor
- Conditions
- Induction of LaborAugmentation of Labor
- Interventions
- Drug: Oxytocin Grindeks 10 IU/ml- solution for injection
- Registration Number
- NCT06990217
- Lead Sponsor
- HaEmek Medical Center, Israel
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 130
- 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
- Women with previous cesarean delivery
- Multiple pregnancy
- Multiple fetal malformations
- IUFD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose oxytocin Oxytocin Grindeks 10 IU/ml- solution for injection 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. Low dose oxytocin Oxytocin Grindeks 10 IU/ml- solution for injection 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 Outcome Measures
Name Time Method Time from the start of oxytocin to delivery 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 Outcome Measures
Name Time Method Maternal satisfaction 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.
Neonatal outcomes up to 1 week neonatal PH\<7.1
Apgar score at 1, 5 and 10 minutes minimum 0 and maximum 10. zero is bad outcome 10 is good outcome
GTPAL system at enrollment GTPAL system assessed by questionnaire
maternal weight at enrollment weight before pregnancy, weight at admission
maternal height at enrollment height
mode of delivery at delivery Maternal age at enrollment maternal age at enrollment
uterine rupture up to 6 weeks after delivery perineal tears during delivery intrapartum fever during labor PPH up to 6 weeks length of postpartum stay perinatal. normally a gravida's length of stay after normal delivery is 48 hours and after c-section is up to 3-4 days.
Trial Locations
- Locations (1)
Haemek Medical Center
🇮🇱Afula, Israel