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Foley catheter versus laminaria for cervical preparation prior to second trimester dilation and evacuation: Open label a non-inferiority randomized trial

Foley catheter versus laminaria for cervical preparation prior to second trimester dilation and evacuation: Open label a non-inferiority randomized trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202408852551318
Enrollment
128
Registered
2024-08-01
Start date
2024-07-22
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Abortion

Interventions

Cervical preparation with Foley catheter prior to second trimester D and E

Sponsors

St. Paul Institute for Reproductive Health and Rights
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: -Women undergoing second trimester D&E -Gestational age at 16-22 weeks -Volunteering to participate in the study Elective D&E procedure

Exclusion criteria

Exclusion criteria: -Incomplete abortion -Molar pregnancy

Design outcomes

Primary

MeasureTime frame
Mean dilation and evacuation- D&E -procedure time (in minutes) after overnight laminaria or Foley catheter placement

Secondary

MeasureTime frame
requirement of additional doses of misoprostol ( 2 or more doses) , Foley or Laminaria insertion to D&E time, D&E complications ( hemorrhage, cervical tear, infection, uterine perforation , failed cervical preparation, and incomplete abortion ), and patient acceptability of the cervical preparation methods

Countries

Ethiopia

Contacts

Public ContactAbraham Fessehaye Sium

SPHMMC

abrahamfessehaye4@gmail.com+251929123745

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026