NCT02202083

Brief Summary

Currently, the study about intervention on the induced abortion at trimester is so little. So, the investigators want to compare the safety and effectiveness of different induced labor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

June 22, 2014

Last Update Submit

June 4, 2015

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Keywords

OxytocinCook Balloon

Outcome Measures

Primary Outcomes (1)

  • The success rate of induced labor

    one year

Study Arms (1)

oxytocin

EXPERIMENTAL

There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon. This group is term gestaion,with bishop score less than 6.

Other: Cook Balloon

Interventions

Cook BalloonOTHER

There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon. This group is term gestaion,with bishop score less than 6.

oxytocin

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestation age ≥37week
  • Single fetus
  • No serious complications

You may not qualify if:

  • Gestation age \<37week
  • Multiple fetus
  • With serious complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Second Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Related Links

Study Officials

  • li zhang, Dr

    West China second Hospital

    STUDY DIRECTOR

Central Study Contacts

li zhang, Dr

CONTACT

+8613882198624

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 22, 2014

First Posted

July 28, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CN(1)