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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01156948
Other study ID # WenzhouMC
Secondary ID
Status Recruiting
Phase Phase 3
First received July 2, 2010
Last updated July 7, 2010
Start date May 2008
Est. completion date December 2011

Study information

Verified date May 2008
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority China: the 1st Affiliated Hospital of Wenzhou Medical College
Study type Interventional

Clinical Trial Summary

To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.


Description:

There is no consensus on the effect of misoprostol on cervical ripening for nulliparous women. The aim of the study is to compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2011
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 40 Years
Eligibility Inclusion Criteria:

- nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.

Exclusion Criteria:

- women with a known allergy to misoprostol.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
misoprostol
400ug vaginally the day before surgery
oral misoprostol
400ug misoprostol orally the day before the surgery

Locations

Country Name City State
China the 1st Affiliated Hospital of Wenzhou Medical College Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary cervical width one day Yes
Secondary side effects one day Yes
See also
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Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT00374621 - Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate N/A
Completed NCT02732522 - Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor Phase 4
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor N/A
Recruiting NCT02738177 - Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation Phase 2
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00468520 - Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial 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
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A