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cervical ripening and termination of term pregnancy

Comparison the Effect of Isosorbide Mononitrate, Laminaria and Trans Cervical Catheter on cervical ripening and termination of term pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014012616368N1
Enrollment
75
Registered
2014-02-22
Start date
2013-09-23
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

Delivery. Pregnancy, childbirth and the puerperium

Interventions

Intervention 1: In first group, Isosorbide Mononitrate, 40 mg of this drug as Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The
Treatment - Drugs
Treatment - Devices
In first group, Isosorbide Mononitrate, 40 mg of this drug as Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third
In the second group, a Foley catheter will be used. Catheter through the cervix will be inserted into the internal orifice of the cervix and balloon with 30 cc of air will be filled.

Sponsors

Qazvin University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Women with term pregnancy that are candidates for induction of labor; Bishop score is less than 4; Presentation of fetus is to be vertex; Nulliparous women.Exclusion criteria: Having a spontaneous contraction; Rupture of membranes; Placenta previa.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Cervical ripening. Timepoint: During at the study (every 4 hours). Method of measurement: Examination of the vagina.

Secondary

MeasureTime frame
Duration of the third stage of labor (from complete expulsion of fetus to the exit of placenta). Timepoint: During at the study. Method of measurement: Observation and examination.;Method of Delivery. Timepoint: During at the study. Method of measurement: Observation and examination.;Maternal complications (Over stimulation of the uterus, postpartum hemorrhage, genital tract lacerations, headaches, nausea, vomiting, and dizziness). Timepoint: During at the study. Method of measurement: Observation and examination.;Duration of first stage of labor (including latent and active phases). Timepoint: During at the study. Method of measurement: Observation and examination.;Duration of the second stage of labor (from full dilatation to expulsion of fetus). Timepoint: During at the study. Method of measurement: Observation and examination.;Neonatal outcomes (Apgar score at first and fifth minutes, sex and birth weight, hospitalization of neonate in the Neonatal Intesive Care Uinte) will be measured. Timepoint: During at the study. Method of measurement: Observation and examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Iranipoor

Qazvin University of Medical Sciences and Health Services

miranipoor@qums.ac.ir+98 28 1223 7267

Outcome results

None listed

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