Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxytocin Grindeks 10 IU/ml- solution for injection.
- Who it may be relevant to
- Registry conditions: Induction of Labor, Augmentation of Labor. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Oxytocin Dosing Regimen' Low Versus High, in Gravida Women With BMI 30 and Above Undergoing Induction of Labor
Overview
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.
Interventions
- Drug Oxytocin Grindeks 10 IU/ml- solution for injection
our study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor
Primary outcome measures
- Time from the start of oxytocin to delivery [Time frame: from the start of induction till delivery]
Secondary outcome measures (12)
- Maternal age [Time frame: at enrollment]
- mode of delivery [Time frame: at delivery]
- intrapartum fever [Time frame: during labor]
- uterine rupture [Time frame: up to 6 weeks after delivery]
- perineal tears [Time frame: during delivery]
- PPH [Time frame: up to 6 weeks]
- length of postpartum stay [Time frame: perinatal.]
- Maternal satisfaction [Time frame: will be assessed up to 1 day after delivery]
- Neonatal outcomes [Time frame: up to 1 week]
- Neonatal outcomes [Time frame: up to 1 week]
- Apgar score [Time frame: at 1, 5 and 10 minutes]
- GTPAL system [Time frame: at enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Haemek Medical Center — Afula
Identifiers
NCT: NCT06990217 · 0022-24-EMC