Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

PHASE3CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 15, 2019

Primary Completion Date

December 15, 2019

Study Completion Date

January 1, 2020

Conditions
Dinoprostone Timing
Interventions
DRUG

long interval dinoprostone

A small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

DRUG

short interval dinoprostone

A small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablet(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

Trial Locations (2)

11231

faculty of medicine Cairo university, Giza

Unknown

Tertiary referral hospital, Giza

All Listed Sponsors
lead

Cairo University

OTHER

NCT04085757 - Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy | Biotech Hunter | Biotech Hunter