Management of Prelabor Rupture of the Membranes at Term

NCT04307069 | Recruiting

• 1 other identifier: Rambam Health-Care Center
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

Conditions

Fetal Infection; Chorioamnionitis; Endometritis; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Maternal infectious morbidity

  Maternal chorioamnionitis and/ or endometritis

  Up to 48 hours postpartum

Secondary Outcomes (3)

• Length of latent and active phases of labor.

  During Labor

• Adverse maternal outcome

  Up to 48 hours postpartum

• Adverse neonatal outcome

  Up to 48 hours postpartum

Study Arms (2)

Immediate oxytocin infusion

EXPERIMENTAL

Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.

Drug: Oxytocin

Expectant management for 24 hours

EXPERIMENTAL

Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.

Drug: Oxytocin

Interventions

Oxytocin DRUG

The drug wil be adminisrate for augmentation of labor at admission.

Also known as: pitocin

Expectant management for 24 hours; Immediate oxytocin infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
• Women at gestational age 370/7 or more.
• Vertex presentation.

You may not qualify if:

• Age 18 and under.
• High order gestation.
• Women with contraindication for a vaginal delivery.
• Active labor.
• Documented fetal anomalies.
• Known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis).
• Non reassuring fetal heart rate tracing.
• Positive group B streptococcus status.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam

Ramat Yishai, 3009500, Israel

RECRUITING

MeSH Terms

Conditions

Chorioamnionitis; Endometritis

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gal Bachar, MD

  Rambam Medical Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gal Bachar, MD

CONTACT

+972524858699; gal.bachar13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)