A clinical trial comparing the safety and efficacy of mifepristone and misoprostol either alone or when used with an intracervical Foleys catheter in women desiring second-trimester medical abortions

Comparative study of mifepristone followed by misoprostol alone or combined with intracervical Foley’s catheter for second-trimester medical abortion - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069578

Enrollment

Registered

2024-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: O00-O08- Pregnancy with abortive outcome

Interventions

Intervention1: Tablet Misoprostol: Tablet Misoprostol 200 or 400 mcg,6 hourly ,per vaginally , for maximum 48 hours Control Intervention1: Foley’s catheter(16 french): 16 French Foley’s catheter inser

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women seeking MTP between 16 to 24 weeks of gestation including women with previous one LSCS 2. Age =18 years 3. Single intrauterine viable pregnancy 4. Women fulfilling the pre-requisites of MTP amendment act, 2021 (India)

Exclusion criteria

Exclusion criteria: 1.Prior 2 or more uterine surgeries 2.Contraindications to mifepristone or misoprostol: ectopic pregnancy, inherited porphyria, chronic adrenal failure, on immunosuppressants (on corticosteroids), coagulation disorders 3.Chorioamnionitis or vaginal infections 4.Any medical or surgical disorders like heart disease , uncontrolled hypertension (=160/100 mm Hg) or diabetes, bronchial asthma or any other medical illness 5.Haemoglobin =8 Gm/dl

Design outcomes

Primary

Measure	Time frame
Comparison of the Induction- abortion interval (IAI) – Time period from initiation of induction (misoprostol only i.e group A or foley’s + misoprostol i.e group B) to expulsion of fetus between above mentioned 2 groups. Timepoint: 11 months	—

Secondary

Measure	Time frame
1.Comparison of completion of abortion within 24 hours between two groups. 2.To compare the need for curettage for retained placental tissue after abortion between two groups 3.To compare the side effects (like vomiting, diarrhoea and fever) between two groups. 4.Comparison of blood loss in both the groups. 5.To compare the Incidence of post abortal infection between two groups.Timepoint: 11 months	—

Measure

Time frame

1.Comparison of completion of abortion within 24 hours between two groups. 2.To compare the need for curettage for retained placental tissue after abortion between two groups 3.To compare the side effects (like vomiting, diarrhoea and fever) between two groups. 4.Comparison of blood loss in both the groups. 5.To compare the Incidence of post abortal infection between two groups.Timepoint: 11 months

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Countries

India

Contacts

Public ContactDr Rashmi Bagga

Postgraduate institute of medical education & research, Chandigarh

rashmibagga@gmail.com9872494602

Outcome results

None listed

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