Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter

Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter: a Multicentre Randomised Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06056141

Enrollment

300

Registered

2023-09-28

Start date

2023-10-01

Completion date

2024-12-01

Last updated

2025-02-21

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

Conditions

Induction of Labor

Keywords

Induction of labor, low dose misoprostol, Foley Catheter

Brief summary

Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.

Detailed description

Open-label randomised trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with 25 μg oral misoprostol once every 2 hour, 2 nd group- a 30 mL transcervical Foley catheter. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, hyperstimulation frequency and hemorrage (for evaluating safety)

Interventions

DRUGMisoprostol 200mcg Tab

Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses

DEVICEFoley Catheter

Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

multicentre randomised controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

* women with an unfavourable cervix who will scheduled for induction of labour

Exclusion criteria

* Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )

Design outcomes

Primary

Measure	Time frame	Description
Efficiency of induction	24 hours.	Number of Participants with vaginal births within 24 hours.

Secondary

Measure	Time frame	Description
Safety for baby	5 min	Rate of cases Apgar score \<7 points
Safety for mother	during the labour induction	incidence of hyperstimulation

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026