Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

NCT ID: NCT04017247

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-06-30

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.

Conditions

Induced; Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermittent treatment

Infusion of oxytocin for 6 hours at a time until patient delivers.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Intermittent oxytocin Infusion

Continous treatment

Infusion of oxytocin continuously from patient admission for 16 hours.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Continous oxytocin Infusion for 16 hours

Interventions

Oxytocin

Intermittent oxytocin Infusion

Intervention Type: DRUG

Oxytocin

Continous oxytocin Infusion for 16 hours

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

ROY LAUTERBACH MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Rambam health care campus

Haifa, , Israel

Countries

Israel

References

Bachar G, Abu-Rass H, Farago N, Justman N, Buchnik G, Chen YS, David CB, Goldfarb N, Khatib N, Ginsberg Y, Zipori Y, Weiner Z, Vitner D. Continuous vs intermittent induction of labor with oxytocin in nulliparous patients: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101176. doi: 10.1016/j.ajogmf.2023.101176. Epub 2023 Oct 7.

Reference Type: DERIVED

PMID: 37813304 (View on PubMed)

Other Identifiers

0308-19-RMB

Identifier Type: -

Identifier Source: org_study_id