Trials / Completed
CompletedNCT04017247
Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
A Comparison Between Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Rambam Health Care Campus · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin | Intermittent oxytocin Infusion |
| DRUG | Oxytocin | Continous oxytocin Infusion for 16 hours |
Timeline
- Start date
- 2019-11-01
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2019-07-12
- Last updated
- 2023-09-13
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04017247. Inclusion in this directory is not an endorsement.