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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose oxytocin | Active Comparator | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin Grindeks 10 IU/ml- solution for injection | Drug | our study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from the start of induction till delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal age | maternal age at enrollment | at enrollment |
| mode of delivery | at delivery | |
| intrapartum fever |
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Inclusion Criteria:
Exclusion Criteria:
only female gravida
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rula Iskander, MD | Contact | +972544357554 | rula_isk@hotmail.com | |
| Galit Garmi | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Rula Iskander, MD | Emek Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Medical Center | Afula | Israel |
to protect patients privacy.
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the two study groups will get the same drug but different dosage.
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| during labor |
| uterine rupture | up to 6 weeks after delivery |
| perineal tears | during delivery |
| PPH | 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. | 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. | will be assessed up to 1 day after delivery |
| Neonatal outcomes | NICU admittion | up to 1 week |
| Neonatal outcomes | neonatal PH<7.1 | up to 1 week |
| Apgar score | minimum 0 and maximum 10. zero is bad outcome 10 is good outcome | at 1, 5 and 10 minutes |
| GTPAL system | GTPAL system assessed by questionnaire | at enrollment |
| maternal weight | weight before pregnancy, weight at admission | at enrollment |
| maternal height | height | at enrollment |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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