NCT04183829

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jun 2019Jun 2028

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

8.5 years

First QC Date

November 28, 2019

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • adverse pregnancy outcomes

    the rate of different adverse pregnancy outcomes

    2028.6

Secondary Outcomes (1)

  • Complications

    2020.6

Interventions

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Zhongshan Boai Hospital

Zhongshan, Guangdong, China

RECRUITING

Zhangjiakou Maternal and Child Health Hospital

Zhangjiakou, Hebei, China

RECRUITING

Daqing People's Hospital

Daqing, Heilongjiang, 150000-160000, China

RECRUITING

Changzhou Maternal and Child Health Hospital

Changzhou, Jiangsu, China

RECRUITING

Yangzhou Maternal and Child Health Hospital

Yangzhou, Jiangsu, China

RECRUITING

People's Hospital of Inner Mongolia Autonomous Region

Hohhot, Mongolia Autonomous, China

RECRUITING

Qingdao Maternal and Child Health Hospital

Qingdao, Shandong, China

COMPLETED

Zaozhuang Maternal and Child Health Hospital

Zaozhuang, Shandong, China

RECRUITING

Taiyuan Maternal and Child Health Hospital

Taiyuan, Shanxi, China

RECRUITING

Tanggu Maternal and Child Health Hospital

Tanggu, Tianjin Municipality, China

COMPLETED

Chongqing Health Center for Women and Children

Chongqing, China

RECRUITING

Shenzhen Luohu Maternity and Child Healthcare Hospital

Shenzhen, China

RECRUITING

MeSH Terms

Interventions

Abortion, Induced

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Pei Kaiyan

    National Research Institute for Family Planning (NRIFP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 3, 2019

Study Start

June 1, 2019

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations