Induced; Birth
Conditions
Brief summary
The study will compare 2 treatment modalities. One group will receive the routine protocol of intermittent pitocin induction for 6 hours and the second group will receive continous pitocin infusion for 16 hours. The primary aim is to observe which protocol leads to the fastest delivery and evaluate the time in each group from induction to delivery.
Detailed description
After singing an informed consent, and prior to IOL initiation, study participants were randomly assigned (1:1) to receive either intermittent or continuous Oxytocin infusion. Both groups received the same primary infusion dose of Oxytocin 1.0 with an incremental increase of 2.5 every 30 minutes until 20, titered to a target of 3-5 contractions in a 10 minute period. During Oxytocin infusion, fetal heart rate was continuously monitored. Artificial ROM was performed according to the accepted indications, local protocol and by the staff physician discretion who was in charge on the labor ward at that time, regardless of oxytocin initiation time. In the intermittent Oxytocin infusion group, Oxytocin was discontinued after 8 h if the patient did not go into active labor during by that time, and renewed 4 h later. In the continuous infusion group, patients received a continuous Oxytocin infusion for 16 h. If they did not go into active labor within this frame time, Oxytocin was discontinued for 4 hours and then resumed. In addition, during Oxytocin infusion, sodium levels were monitored every 8 h.
Interventions
DRUGOxytocin
Intermittent oxytocin Infusion
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women with a singleton pregnancy that are admitted for induction or augmentation of labor. 2. Women at gestational age 370/7 or more. 3. Vertex presentation.
Exclusion criteria
1. Age under 18 or over 45. 2. High order gestation. 3. Women with contraindication for vaginal delivery. 4. Active labor. 5. Women with a uterine scar. 6. Multiparity(\> 5 deliveries). 7. Documented fetal anomalies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery within 24 hours | from admission up to 24 hours postpartum | The percentage of women delivering within 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| caesarian deliveries | from admission up to 24 hours postpartum | The rate of caesarian deliveries. |
| instrumental deliveries | from admission up to 24 hours postpartum | The rate of instrumental deliveries. |
| latent phase of labor. | from admission up to 24 hours postpartum | Length of latent phase of labor. |
| active phase of labor. | from admission up to 24 hours postpartum | Length of active phase of labor. |
Countries
Israel
Outcome results
None listed