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Comparison of the effect of vaginal misoprostol and Evening primrose Capsule on the state of delivery

Comparison of the effect of vaginal misoprostol alone and in combination with Evening primrose Capsule on the state of delivery in pregnant women candidate for pregnancy termination

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210113050028N2
Enrollment
30
Registered
2022-05-01
Start date
2022-05-21
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Normal Vaginal Delivery.

Interventions

Intervention 1: Intervention group: Receiving 1000 mg vaginal capsule of evening primrose with the use of 25 µg vaginal mesopzostol by Pfizer. Intervention 2: Control group: Vaginal view medication an

Sponsors

Ardabil University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Single pregnancy live fetus Fetal weight less than 4 kg Amniotic fluid index more than 5 cm normal fetus NST Bishop score less than 7 Absence of labor pains in the mother

Exclusion criteria

Exclusion criteria: Rupture of membranes Possibility of fetal abnormalities need for urgent delivery Hypersensitivity to prostaglandins and evening primrose History of seizures history of schizophrenia with phenothiazin Prescription Bleeding disorders or taking anticoagulants Fallen in FHR Malpresentation Fetal disorders such as hydrocephalia

Design outcomes

Primary

MeasureTime frame
Amount of pain. Timepoint: Pain measurement scale based on counting between two contractions. Method of measurement: Pain scale: The amount of pain between zero no pain and 10 most severe pain possible.;Vaginal bleeding. Timepoint: During labor. Method of measurement: The amount of vaginal bleeding.;Infant Weight. Timepoint: After birth. Method of measurement: Weighing the baby.;Infant APGAR. Timepoint: 0-5-10 minutes after birth. Method of measurement: According to the standard Apgar score of infants.;Latent & active phase duration. Timepoint: From the onset of labor symptoms to the end of the active phase. Method of measurement: Latent & active phase duration.;Cervical dilatation. Timepoint: 0-10 cm. Method of measurement: Induction of cervical dilatation before and after.

Secondary

MeasureTime frame
Duration of latent phase of labor. Timepoint: from the beginning of contractions to dilatation 3-6 cm. Method of measurement: Vaginal examination.;Active phase of labor. Timepoint: From dilatation of 3-6 cm to the birth of a baby. Method of measurement: Vaginal examination.;Method of delivery. Timepoint: Decide on the method of termination of labor. Method of measurement: Termination method of pregnancy.;The volume of postpartum hemorrhage. Timepoint: Until the end of the labor phase. Method of measurement: Number of bloody pads.;Pain intensity. Timepoint: every 30 minutes to 2 hours. Method of measurement: Visual Analogue Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNoushin Mobaraki-asl

Ardabil University of Medical Sciences

n.mobaraki@arums.ac.ir+98 45 3323 5861

Outcome results

None listed

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