cervical ripening and termination of term pregnancy

The Effects of vaginal Misoprostol, Laminaria and Isosorbide Dinitrate on cervical ripening before labor induction among the term parturients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016050527643N2

Enrollment

Registered

2016-05-23

Start date

2016-05-17

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

vaginal delivery. Spontaneous vertex delivery

Interventions

Intervention 1: in the first group, Misoprostol, 25 microgram of this drug as oral Tablet will insert in posterior fornix of vagina.The dose can be repeated up to 2 times every 6 hours. The second dos

Treatment - Drugs

Treatment - Devices

in the first group, Misoprostol, 25 microgram of this drug as oral Tablet will insert in posterior fornix of vagina.The dose can be repeated up to 2 times every 6 hours. The second doses, if Bishop s

in the second group, Isosorbide Dinitrate, 40 milligram of this drug as Oral Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The s

In third group, first, maternal vagina will be cleaned with Bethadine. After the Speculum inserted, the anterior lip of the Cervix will be taken with Tenaculum and Laminaria will be taken down dependi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria:term pregnancy ; bishop score less than 6 ; cephalic presentation ; singleton pregnancy Exclusion criteria:use of another way for cervical ripenig ; contraindication of labor inducton or NVD ; mother's comorbidity ; rupture of fetus membrane ; severe preeclampsia ; vaginal bleeding ; Placenta previa ; having a spontaneous contraction

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Cervical ripening. Timepoint: On admissiom and 12 hours later and before insertion of each dose. Method of measurement: Vaginal exam based on Bishop score.	—

Secondary

Measure	Time frame
Maternal complications (Over stimulation of the uterus, headaches, tachycardia, hypotension, nausea, vomiting, and dizziness). Timepoint: During at the intervention. Method of measurement: Observation and Examination.;Method of delivery. Timepoint: During at the intervention. Method of measurement: Observation and Examination.;Duration of the first stage of labor. Timepoint: Active stage of labor. Method of measurement: Hour.;Neonatal outcomes (Apgar score at first and fifth minutes, birth weight, hospitalization of neonate in the Neonatal Intensive Care Unit). Timepoint: During at the intervention. Method of measurement: Observation and Examination.;Necessity of induction. Timepoint: During at the intervention. Method of measurement: Observation and Examination.	—

Measure

Time frame

Maternal complications (Over stimulation of the uterus, headaches, tachycardia, hypotension, nausea, vomiting, and dizziness). Timepoint: During at the intervention. Method of measurement: Observation and Examination.;Method of delivery. Timepoint: During at the intervention. Method of measurement: Observation and Examination.;Duration of the first stage of labor. Timepoint: Active stage of labor. Method of measurement: Hour.;Neonatal outcomes (Apgar score at first and fifth minutes, birth weight, hospitalization of neonate in the Neonatal Intensive Care Unit). Timepoint: During at the intervention. Method of measurement: Observation and Examination.;Necessity of induction. Timepoint: During at the intervention. Method of measurement: Observation and Examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Haeri

Sabzevar University of Medical Sciences

haeri.sima@yahoo.com+98 51 3864 3035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 6, 2026