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preparation for delivery in late pregnancy

Comparison of vaginal Isosorbaid mononitrat and vaginal estradiol and placebo effect on cervix ripening in post term pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015053122507N1
Enrollment
99
Registered
2015-08-21
Start date
2015-06-06
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 Isosorbaid mononitrat and vaginal estradiol and Placebo effect on cervix ripening. Disorders related to long gestation and high birth weight

Interventions

Treatment - Drugs
Placebo
Intervention 1: From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the vaginal isosorbide mononitrat
From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the vaginal isosorbide mononitrate group, 1 table
From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the vaginal estradiol group, 1 tablet 25 micro g
From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the Placebo group, 1 Placebo tablet placed in th

Sponsors

Deputy Director of Research and Technology of Ardabil University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: singleton pregnancy; cephalic presentation; intact membranes; BS less than 6; the result of normal fetal health monitoring; lack of uterine contractions; the absence of systemic problems in the history; clinical examination; age 15 to 35 Exclusion criteria: women with preeclampsia; history of previous cesarean; active genital herpes; poly Hydramnious; placenta previa or placental abruption risk; membrane rupture; history of Cardiac or respiratory disease; the presence of any contra indication for labor induction; systolic blood pressure less than 90 mmHg

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bishop score (cervix ripening). Timepoint: at the visit, 12 hours and 24 hours later. Method of measurement: Vaginal examination (According to Williams reference table to determine the Bishop score).

Secondary

MeasureTime frame
From active phase to full dilatation. Timepoint: During the study. Method of measurement: Observation and examination.;From full dilatation to delivery. Timepoint: During the study. Method of measurement: Observation and examination.;From Induction to active phase. Timepoint: During the study. Method of measurement: Observation and examination.;Delivery. Timepoint: During the study. Method of measurement: Observation and examination.;Maternal side effects (headache, nausea, vomiting, and dizziness). Timepoint: During the study. Method of measurement: Observation and examination.;The consequences of neonatal (first and fifth minute Apgar score, gender and birth weight, infant hospitalized in the Intensive Care Unit, Meconium defecation). Timepoint: During the study. Method of measurement: Observation and examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNushin Chamheidar

Ardabil University of Medical Sciences

nushin.chamheidar@gmail.com+98 45 3326 1714

Outcome results

None listed

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