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A study for the safety and effectiveness of immediate postpartum insertion of GyneFix intrauterine device for postpartum contraception: a phase IV clinical trial

A study for the safety and effectiveness of immediate postpartum insertion of GyneFix intrauterine device for postpartum contraception: a phase IV clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023828
Enrollment
Unknown
Registered
2019-06-13
Start date
2018-01-02
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unintended pregnancy and induced abortion

Interventions

Case series:IUD insertion immediately after CS

Sponsors

Shanghai Institute of Planned Parenthood Research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. healthy women aged between 20-45 years; 2. successful Caesarean section; 3. normal placental expulsion, Placental residue

Exclusion criteria

Exclusion criteria: 1. parafunction of blood coagulation and other haemotaological diseases; 2. premature rupture of fetal membranes more than 24 hours; 3. twins or multiple births; 4. refuse to sign ICF; 5. With heavy bleeding duing Caesarean section (=500ml); 6. potential risks of bleeding and infection. 7. other conditions that are judged by doctors.

Design outcomes

Primary

MeasureTime frame
Volume of bleeding;infection during the period of puerperium;lochia sanguinea;time length of lochia after child birth;

Secondary

MeasureTime frame
contraceptive failure;IUD expulsion;success rate of IUD insertion;

Countries

China

Contacts

Public ContactChe Yan

Shanghai Institute of Planned Parenthood Research

cheyan2004@163.com+86 021 64771556

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026