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NCT04215835 Clinical Trial

Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage

Missed Abortion Clinical Trial

Official title:
Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04215835
Other study ID # letrozole pretreatment
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 5, 2020
Est. completion date April 10, 2020

Study information
Verified date December 2019
Source Cairo University
Contact AHMED SAMY
Phone +201100681167
Email ahmedsamy8233@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date April 10, 2020
Est. primary completion date April 5, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Gestational age less than 64 days gestation (<9 wks).

- Hemoglobin >10 g/dL.

- BMI between 18.5 kg/m2 and 25 kg/m2.

- Missed abortion.

- previous one or more cesarean delivaries

Exclusion Criteria:

- Molar pregnancy.

- Fibroid uterus.

- Uterine anomalies.

- Coagulopathy.

- Medical disorder that contraindicate induction of abortion (e.g. heart failure).

- Previous attempts for induction of abortion in the current pregnancy.

- Allergy to misoprostol or letrozole.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• letrozole then misoprostol
Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
• placebo then misoprostol
Drug: Placebo placebo for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary induction to abortion time induction to abortion time 6 hours
Primary Incidence of complete miscarriage Incidence of complete miscarriage 6 hours
Secondary Need for surgical evacuation of the products of conception Need for surgical evacuation of the products of conception 6 hours
See also
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Recruiting NCT03628625 - Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage Phase 2
Completed NCT03584698 - Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage Phase 4
Active, not recruiting NCT05516810 - The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
Not yet recruiting NCT04590482 - Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion Phase 4
Recruiting NCT05342467 - Gemeprost Versus Dinoprostone in First Trimester Miscarriages Phase 2
Recruiting NCT03698734 - Evening Primrose Oil Efficacy in Second Trimester Abortion Phase 3
Terminated NCT01615224 - Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage Phase 2/Phase 3
Completed NCT05216952 - Ulipristal Acetate for Use in Early Pregnancy Loss Phase 2
Recruiting NCT03081104 - Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion N/A
Completed NCT00892229 - Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil Phase 2
Active, not recruiting NCT04981457 - Comparative Study Between Combined Vaginal Misoprostol Phase 1
Not yet recruiting NCT06469203 - Oxytocin Effectiveness in First Trimester Dilatation and Curettage - a Double Blind Placebo Controlled Randomized Trial N/A
Recruiting NCT02573051 - Termination Of Anembryonic Pregnancy Phase 2
Not yet recruiting NCT04217265 - Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion Phase 4
Recruiting NCT04705324 - Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion N/A
Completed NCT02686840 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage Phase 3
Terminated NCT02342002 - Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial Phase 4
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Active, not recruiting NCT04593108 - Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage