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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03854383
Other study ID # 600181
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 3, 2019
Est. completion date July 1, 2019

Study information

Verified date March 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- age (20-35 yrs)

- single fetus

- gestational age > 40weeks

- not in labor

- bishop score < 7

- no medical disorder

Exclusion Criteria:

- Gestational age =40 weeks

- patient with a ripe cervix

- rupture of membranes

- suspected chorioamnionitis

- placenta previa

- history of major uterine surgery

- hypertonic uterine pattern

- contraindicated to receive PG

- fetal malpresentation

- multiple pregnancy

- intrauterine growth retardation

- women with any general medical disorder

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Isosorbide mononitrate
Administration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women
Misoprostol
Used intravaginally to ripe the cevix in induction of labor

Locations

Country Name City State
Egypt Ain Shams maternity hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Abdelrahman Ali Fadel Youssef Mohamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The duration of induction to active phase interval Measure the time between the beginning of the induction to enter the active phase of labor 12 weeks
See also
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Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
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Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
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Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A
Completed NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb Early Phase 1