Assessing the effect of cervical ripening baloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor

Labor induction with unfavorable cervix; Assessing the effect of cervical ripening balloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120718010324N56

Enrollment

Registered

2020-06-22

Start date

2020-06-21

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Labor induction. Other specified assisted single delivery

Interventions

Intervention 1: Intervention group 1: vaginal capsule evening primrose oil 4000 mg. Intervention 2: Intervention group 2: Double balloon cervical ripening catheter. Intervention 3: Intervention group

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Gestational age= 40 weeks Vertex presentation Parity = 4 Single pregnancy Lack of vaginal delivery contraindication Uncomplicated pregnancy Bishop score less than 4 Favorable non stress test in admission Lack of effective uterine contractions (less than three contractions in 30 minutes) Intact amniotic sac

Exclusion criteria

Exclusion criteria: Amniotic fluid volume Disorders Intra Uterine Growth Retardation Fetal macrosomia Any contraindication for evening primrose oil use such as history of seizures in the mother or use of anticonvulsant drugs Contraindication for labor induction High risk pregnancy Existence of chronic or systemic disease such as diabetes and hypertension Existence of scar on the uterus

Design outcomes

Primary

Measure	Time frame
Bishop score. Timepoint: Before intervention and every 4 hours after intervention until 12 hours. Method of measurement: Bishop scoring scale.;Duration of first stage of labor. Timepoint: From beginning of induction until childbirth. Method of measurement: Partograph.	—

Secondary

Measure	Time frame
Duration of second stage of labor. Timepoint: After full dilatation. Method of measurement: Partograph.;Duration of third stage of labor. Timepoint: After neonatal delivery until deliver the placenta. Method of measurement: Partograph.;Type of delivery (cesarean section rate). Timepoint: After delivery. Method of measurement: Researcher's designed form.;First and fifth minute Apgar score. Timepoint: After delivery. Method of measurement: Baby profile sheet.;Use of oxytocin for labor induction. Timepoint: During labor. Method of measurement: Partograph and labor process improvement sheet.;Mean score of birth satisfaction. Timepoint: 12- 24 hours after delivery. Method of measurement: Birth Satisfaction Scale- revised (BSS-R).;Side effects. Timepoint: During labor and after delivery. Method of measurement: Researcher's designed form.	—

Measure

Time frame

Duration of second stage of labor. Timepoint: After full dilatation. Method of measurement: Partograph.;Duration of third stage of labor. Timepoint: After neonatal delivery until deliver the placenta. Method of measurement: Partograph.;Type of delivery (cesarean section rate). Timepoint: After delivery. Method of measurement: Researcher's designed form.;First and fifth minute Apgar score. Timepoint: After delivery. Method of measurement: Baby profile sheet.;Use of oxytocin for labor induction. Timepoint: During labor. Method of measurement: Partograph and labor process improvement sheet.;Mean score of birth satisfaction. Timepoint: 12- 24 hours after delivery. Method of measurement: Birth Satisfaction Scale- revised (BSS-R).;Side effects. Timepoint: During labor and after delivery. Method of measurement: Researcher's designed form.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahla Hemmatzadeh

Tabriz University of Medical Sciences

shahla_obs@yahoo.com+98 41 3479 6770

Outcome results

None listed

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