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Medical methods for First trimester abortion upto 10weeks

A randomised controlled trial of mifepristone followed by misoprostol 6-8hrs versus 23-25hrs for abortion upto 10weeks of gestation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039355
Enrollment
120
Registered
2022-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Mifepristone Misoprostol: Mifepristone 200mg given orally followed by misoprostol 800mcg pervaginally after 6-8hrs of mifepristone Control Intervention1: Mifepristone Misoprostol: Mifep

Sponsors

SDM College of medical sciences and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Only women with a visible intrauterine gestational sac were enrolled. Mean sac diameter (length width depth/3) was used to determine estimated gestational age (EGA) only when an embryonic pole was absent. Last menstrual period was used to determine EGA if the last menstrual period was within 3 days of the ultrasound EGA; however, the ultrasound estimate was used if it differed by 4 days or more from the EGA by last menstrual period.

Exclusion criteria

Exclusion criteria: Potential subjects were EXCLUDED if they had any contraindication to mifepristone, including chronic systemic corticosteroid administration or adrenal disease; had any contraindications to misoprostol, including glaucoma, mitral stenosis, sickle cell anemia, poorly controlled seizure disorder, or known allergy to prostaglandin; had cardiovascular disease, including angina, valvular disease, arrhythmia, or cardiac failure; had a known coagulopathy or were receiving treatment with anticoagulants; had a pregnancy with an intrauterine device in utero; had active cervicitis on examination; if their ultrasound examination results demonstrated any evidence of an early pregnancy failure, had previously participated in the trial.

Design outcomes

Primary

MeasureTime frame
to compare- complete abortion rates in women who received mifepristone followed by vaginal misoprostol 6 to 8 hours later (experimental group) and 24 hours later (standard care group) Timepoint: Complete abortion

Secondary

MeasureTime frame
side effects, bleeding, and acceptabilityTimepoint: Side effects, bleeding and acceptability

Countries

India

Contacts

Public Contactmahalakshmi gaddi

SDM College of medical sciences and hospital

mahagaddi@gmail.com9686991664

Outcome results

None listed

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