Reproductive HealthNCT04183829
Effects of Prior Induced Termination of Pregnancy on Complications and Pregnancy Outcomes.
An observational study of Reproductive Health and Abortion, run by National Research Institute for Family Planning, China at 12 sites in China.
Trial summary
A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Reproductive Health, Abortion
- What is being tested?
- induced termination of pregnancy
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 12 sitesChina
- Study dates
- 1 Jun 2019to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: women who have induced abortion in early pregnancy (<12 weeks of gestation)
Who may be able to join
- 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.
Who cannot join
- above the age of 40
- with history of adverse pregnancy and childbirth
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 10 recruiting
- Recruiting
Changzhou Maternal and Child Health Hospital
Changzhou, Jiangsu
- Recruiting
Chongqing Health Center for Women and Children
Chongqing
- Recruiting
Daqing People's Hospital
Daqing, Heilongjiang, 150000-160000
Tu Pengcheng, M.D.
- Recruiting
People's Hospital of Inner Mongolia Autonomous Region
Hohhot, Mongolia Autonomous
Tu Pengcheng, M.D.
- Completed
Qingdao Maternal and Child Health Hospital
Qingdao, Shandong
- Recruiting
Shenzhen Luohu Maternity and Child Healthcare Hospital
Shenzhen
- Recruiting
Taiyuan Maternal and Child Health Hospital
Taiyuan, Shanxi
- Completed
Tanggu Maternal and Child Health Hospital
Tanggu, Tianjin Municipality
- Recruiting
Yangzhou Maternal and Child Health Hospital
Yangzhou, Jiangsu
- Recruiting
Zaozhuang Maternal and Child Health Hospital
Zaozhuang, Shandong
- Recruiting
Zhangjiakou Maternal and Child Health Hospital
Zhangjiakou, Hebei
Tu Pengcheng, M.D.
- Recruiting
Zhongshan Boai Hospital
Zhongshan, Guangdong
About this study
A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.
Read the detailed description
A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.
- Conditions
- Reproductive Health, Abortion
- Being tested
- induced termination of pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induced termination of pregnancyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse pregnancy outcomes
the rate of different adverse pregnancy outcomes
Measured: 2028.6
Secondary outcomes (1)
Complications
the rate of different complications
Measured: 2020.6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Jun 2019
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Institute for Family Planning, China
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pei Kaiyan, Principal investigator, National Research Institute for Family Planning (NRIFP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183829
- Sponsor's protocol ID
- No.2018-I2M-1-004
- Status last verified
- Sep 2025
- First submitted
- 28 Nov 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prior Induced Termination of Pregnancy on Complications and Pregnancy Outcomes.
- ClinicalTrials.gov ID
- NCT04183829
- Acronym / sponsor ID
- No.2018-I2M-1-004
- Conditions
- Reproductive Health, Abortion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- National Research Institute for Family Planning, ChinaOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women who have induced abortion in early pregnancy (<12 weeks of gestation)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- above the age of 40
- with history of adverse pregnancy and childbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induced termination of pregnancyMedically, 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. | Procedure or surgery | – |
Primary outcome
adverse pregnancy outcomes
Time frame: 2028.6
the rate of different adverse pregnancy outcomes
1 secondary outcome
Complications
Time frame: 2020.6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei Kaiyan principal investigator
National Research Institute for Family Planning (NRIFP)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Health and Abortion, run by National Research Institute for Family Planning, China at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Xue, M.D. (+86 18011490663, jiangxue012800@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse pregnancy outcomes (time frame: 2028.6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.