Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion.

Early Pregnancy Clinical Trial

Official title:

Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion in Young Pregnancy - A Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03440866
• Other study ID #: 2-17 EMC
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. There is little data to compare the efficacy of concomitant administration of both drugs and different time intervals.

This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.

Description:

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). According to the original protocol ,the administration of oral Mifepristone 600 mg is followed by oral Misoprostol 400 mcg in an interval of 36 to 48 hours. Shortening this time interval may convince patients to avoid surgical termination of pregnancy, enhance patient's compliance to treatment and even be more economically.

The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. The patients are recommended to have an ultrasound examination after 2 to 3 weeks. There is little data to compare the efficacy of concomitant administration of both drugs according to the dosage of this protocol and different time intervals.

This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.

Participants in the study group will be given both drugs at the same time while participants in the control group will be given Mifepristone and Misoprostol in an interval of 48 hours.

The investigators hypothesis is that administration of both drugs concomitantly will not change significantly the success rate of the procedure and will not enhance the side effects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• intrauterine singleton pregnancy of less than 49 days, reassured by ultrasound examination

• patient who desire to terminate their pregnancy and have approval of the committee for termination of pregnancy

• patient who gave their consent to have a surgical abortion eventual if needed

Exclusion Criteria:

• contraindication to Mifepristone or Misoprostol

• suspected ectopic pregnancy

• systemic treatment with steroids

• adrenal insufficiency

• heart and blood vessels disease

• coagulopathy or use of anti-thrombotic agents

• uncontrolled asthma

• liver or kidney insufficiency

• anorexia

• intrauterine device

• breastfeeding

Related Conditions & MeSH terms

• Early Pregnancy

Intervention

Drug:
• Administration of drugs concomitantly.
Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.

Locations

Country	Name	City	State
Israel	HaEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (13)

Creinin MD, Fox MC, Teal S, Chen A, Schaff EA, Meyn LA; MOD Study Trial Group. A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Obstet Gynecol. 2004 May;103(5 Pt 1):851-9. doi: 10.1097/01.AOG.0000124271. — View Citation

Creinin MD, Schreiber CA, Bednarek P, Lintu H, Wagner MS, Meyn LA; Medical Abortion at the Same Time (MAST) Study Trial Group. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):885-94. doi: 10.1097/01.AOG.0000258298.35143.d2. — View Citation

Creinin MD, Schwartz JL, Pymar HC, Fink W. Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial. BJOG. 2001 May;108(5):469-73. doi: 10.1111/j.1471-0528.2001.00117.x. — View Citation

Garg G, Takkar N, Sehgal A. Buccal versus vaginal misoprostol administration for the induction of first and second trimester abortions. J Obstet Gynaecol India. 2015 Apr;65(2):111-6. doi: 10.1007/s13224-014-0605-5. Epub 2014 Oct 31. — View Citation

Goel A, Mittal S, Taneja BK, Singal N, Attri S. Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2011 Jun;283(6):1409-13. doi: 10.1007/s00404-011-1881-2. Ep — View Citation

McKinley C, Thong KJ, Baird DT. The effect of dose of mifepristone and gestation on the efficacy of medical abortion with mifepristone and misoprostol. Hum Reprod. 1993 Sep;8(9):1502-5. doi: 10.1093/oxfordjournals.humrep.a138287. — View Citation

Murthy AS, Creinin MD, Harwood B, Schreiber C. A pilot study of mifepristone and misoprostol administered at the same time for abortion up to 49 days gestation. Contraception. 2005 May;71(5):333-6. doi: 10.1016/j.contraception.2004.10.006. — View Citation

Schaff E. Evidence for shortening the time interval of prostaglandin after mifepristone for medical abortion. Contraception. 2006 Jul;74(1):42-4. doi: 10.1016/j.contraception.2006.03.014. Epub 2006 May 12. — View Citation

Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. 2001 Aug;64(2):81-5. doi: 10.1016/s0010-7824(01)00229-3. — View Citation

Termination of pregnancy with reduced doses of mifepristone. World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation. BMJ. 1993 Aug 28;307(6903):532-7. doi: 10.1136/bmj.307.6903.532. — View Citation

von Hertzen H, Piaggio G, Wojdyla D, Marions L, My Huong NT, Tang OS, Fang AH, Wu SC, Kalmar L, Mittal S, Erdenetungalag R, Horga M, Pretnar-Darovec A, Kapamadzija A, Dickson K, Anh ND, Tai NV, Tuyet HT, Peregoudov A; WHO Research Group on Post-ovulatory — View Citation

Wedisinghe L, Elsandabesee D. Flexible mifepristone and misoprostol administration interval for first-trimester medical termination. Contraception. 2010 Apr;81(4):269-74. doi: 10.1016/j.contraception.2009.09.007. Epub 2009 Oct 29. — View Citation

World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation; Special Programme of Research, Development and Research Training; World Health Organisation. Comparison of two doses of mifepristone in combination with misoprostol fo — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of complete abortion	Success rate of complete abortion without any other surgical intervention	two weeks
Secondary	Bleeding amount	Assessment of bleeding amount and duration by the patient (maximum amount of pads per day) and Hemoglobin level before and two weeks after the procedure	two weeks
Secondary	Self reported pain intensity after two weeks	Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain during those two weeks.	two weeks
Secondary	patient's satisfaction	Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction. the patient will be asked if she will select this method next time if necessary	two weeks