Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

NCT02416583 | Completed DMC

• 1 other identifier: SWP_PG_N2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix

Conditions

Failed Induction of Labor

Keywords

membrane sweeping; dinoprostone; nulliparas; labor induction

Outcome Measures

Primary Outcomes (1)

• Vaginal delivery within 24 hours

  Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.

  From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours

Secondary Outcomes (3)

• Successful labor induction

  From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours

• Incidence of cesarean delivery

  End of labor induction (assessed up to 120 hours)

• The interval from start of oxytocin to delivery

  From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours

Study Arms (2)

Oxytocin & Membrane sweeping

ACTIVE COMPARATOR

Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day

Drug: Oxytocin; Procedure: Membrane sweeping

Oxytocin & Dinoprostone

ACTIVE COMPARATOR

For women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day

Drug: Oxytocin; Drug: Dinoprostone

Interventions

Oxytocin DRUG

Oxytocin & Dinoprostone; Oxytocin & Membrane sweeping

Dinoprostone DRUG

Oxytocin & Dinoprostone

Membrane sweeping PROCEDURE

Oxytocin & Membrane sweeping

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• singleton pregnancy
• Nulliparous women
• gestational age \>=37.0 weeks
• Bishop score \<=6
• intact amniotic membrane
• absence of labor
• live fetus with vertex presentation
• no previous uterine surgical procedure

You may not qualify if:

• Multiple pregnancy
• Placenta previa

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Oxytocin; Dinoprostone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Kyo Hoon Park, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

KR (1)