A Phase 4 interventional study of Oxytocin Grindeks 10 IU/ml- solution for injection in Induction of Labor and Augmentation of Labor, sponsored by HaEmek Medical Center, Israel. Not yet recruiting at 1 site in Israel. Open to female participants. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by HaEmek Medical Center, Israel · Phase 4, Interventional, and Treatment
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)
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 130 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
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
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
Maternal age
maternal age at enrollment
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
normally a gravida's length of stay after normal delivery is 48 hours and after c-section is up to 3-4 days.
Time frame: perinatal.
Maternal satisfaction
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.
Time frame: will be assessed up to 1 day after delivery
Neonatal outcomes
NICU admittion
Time frame: up to 1 week
Neonatal outcomes
neonatal PH\<7.1
Time frame: up to 1 week
Apgar score
minimum 0 and maximum 10. zero is bad outcome 10 is good outcome
Time frame: at 1, 5 and 10 minutes
GTPAL system
GTPAL system assessed by questionnaire
Time frame: at enrollment
maternal weight
weight before pregnancy, weight at admission
Time frame: at enrollment
maternal height
height
Time frame: at enrollment
Plan to share: No — to protect patients privacy.
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Jun 2027, 24 months later.
Of 190 non-industry phase 4 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 24 months is below that.
Counting every sponsor, half of 210 studies reached it within 31 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel →