Effects of Prior Induced Termination of Pregnancy on Comp... | NCT04183829

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Nov 28, 2019

First Submission Date that Met QC Criteria

Nov 28, 2019

First Posted Date

Dec 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2025

Last Update Posted Date

Sep 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.

Detailed Description

A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
induced termination of pregnancy	Procedure	Medically, induced termination of pregnancy (I-TOP) is defined as an intervention to voluntarily terminate a pregnancy (ie, induced abortion) by either surgical or medical means so it does not result in a live birth.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adverse pregnancy outcomes	the rate of different adverse pregnancy outcomes	2028.6

Secondary Outcomes

Measure	Description	Time Frame
Complications	the rate of different complications	2020.6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women have induced abortion in early pregnancy (<12 weeks of gestation).
permanent population and no tendency to move.
normal language expression and understanding ability, able to understand research content.
be able and willing to provide written informed consent and effective contact information, and be willing to cooperate with follow-up investigations.

Exclusion Criteria:

above the age of 40
with history of adverse pregnancy and childbirth

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

women who have induced abortion in early pregnancy (<12 weeks of gestation)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiang Xue, M.D.	Contact	+86 18011490663		jiangxue012800@163.com

Overall Officials

Name	Affiliation	Role
Pei Kaiyan	National Research Institute for Family Planning (NRIFP)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Boai Hospital	Recruiting	Zhongshan	Guangdong		China
Zhangjiakou Maternal and Child Health Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative