Augmentation of Labor, Induction of Labor
Conditions
Keywords
induction of labor, augmentation of labor, obese, obese gravida, high dose of oxytocin in obese gravida
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.
Interventions
DRUGOxytocin 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
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
the two study groups will get the same drug but different dosage.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| mode of delivery | at delivery | — |
| intrapartum fever | during labor | — |
| uterine rupture | up to 6 weeks after delivery | — |
| perineal tears | during delivery | — |
| 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. |
| Maternal age | at enrollment | maternal age at enrollment |
| Neonatal outcomes | up to 1 week | NICU admittion |
| 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 |
| 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. |
Countries
Israel
Contacts
Primary ContactRula Iskander, MD
Backup ContactGalit Garmi
Outcome results
None listed