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Comparison between Misoprostol and foley catheter for cervical ripening.

Misoprostol versus foley catheter for cervical ripening in women with preeclampsia or gestational hypertension.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017010731725N1
Enrollment
125
Registered
2017-02-20
Start date
2015-01-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: preeclampsia. Condition 2: gestational hypertention. Pre-eclampsia, unspecified Gestational [pregnancy-induced] hypertension without significant proteinuria

Interventions

Intervention 1: In misoprostol group: 25 micro grams of misoprostol tablet was administered sublingually every 4 hours up to maximum dose of 6 during cervical ripening. Intervention 2: In foley cathet
Treatment - Drugs
Treatment - Devices
In misoprostol group: 25 micro grams of misoprostol tablet was administered sublingually every 4 hours up to maximum dose of 6 during cervical ripening.
In foley catheter group: A 16 F foley catheter was inserted through internal os of cervix under aseptic condition and it was inflated with 60 cc of sterile salin. This intervention was performed durin

Sponsors

Research assistance of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- pregnant women with preeclampsia or gestational hypertension 2- Singleton pregnancy 3- Gestational age of 26 weeks or more 4- Absence of active labour 5- Cephalic presentation 6- Unfavorable cervix ( bishop score of 6 or less) 7- Normal FHR 8- Intact membrane. Exclusion Criteria: 1- Hypersensitivity to Prostaglandins 2- Previous Cesarean section 3- Previous uterine scar 4- Macrosomia 6- lethal congenital anomalies 7- Placenta previa.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Interval between induction commencement and obtaining bishop score of 6. Timepoint: During intervention. Method of measurement: In hour unit obtained by manual vaginal exam.

Secondary

MeasureTime frame
Delivery before 24 hours. Timepoint: up to 24 hours after intervention. Method of measurement: in hour unit obtained by questionnaire.;Neonatal complications. Timepoint: up to 24 hours after birth. Method of measurement: questionnaire and apgar score.;Oxytocin requirement. Timepoint: during intervention. Method of measurement: questionnaire.;Maternal complications. Timepoint: 24 hours after delivery. Method of measurement: questionnaire.;Duration of the second stage of delivery. Timepoint: maximum 3 hours after complete dilatation and effacement. Method of measurement: in minute unit obtained by questionnaire.;Cesarean delivery incidence. Timepoint: up to 48 hours after intervention. Method of measurement: percentage unit obtained by questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElahe Hassanzadeh

Mashhad University of Medical Sciences

hassanzadehe871@mums.ac.ir+98 513867791

Outcome results

None listed

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