Second Trimester Medical Abortion

NCT04160221 | Completed

• 1 other identifier: 6416-19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, have revealed shorter total abortion time with shorter intervals. In this study we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals

Conditions

Medical Abortion, Complete or Unspecified, Without Complication

Keywords

Medical Abortion; Mifepristone; Misoprostol

Outcome Measures

Primary Outcomes (1)

• Induction-abortion time

  Total induction to complete abortion ( estimated by hours)

  Through completion of abortion, an estimated period of up to 3 days

Secondary Outcomes (3)

• Fever

  From the beginning until completion of abortion,estimated up to two weeks

• Excessive blood loss

  From the beginning until completion of abortion, estimated up to two weeks

• Any emergency department visit

  From the beginning until completion of abortion, estimated up to two weeks

Study Arms (2)

12 hours interval

ACTIVE COMPARATOR

Mifepristone followed by Misoprostol treatment

Other: 12 hours interval

24 hours interval

ACTIVE COMPARATOR

Mifepristone followed by Misoprostol treatment

Other: 24 hours interval

Interventions

12 hours interval OTHER

Time interval between treatments

12 hours interval

24 hours interval OTHER

Time interval between treatments

24 hours interval

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 years and older about to undergo medical second trimester abortion
• +0 to 28+0 weeks of gestation
• Singleton intrauterine pregnancy
• Able to sign informed consent

You may not qualify if:

• Inability to give informed consent
• Allergy to any of the drugs used in the study
• Genital bleeding of unknown etiology; cancer of the breast, cervix, uterus, or ovaries; hepatic disease (current or history of)
• Multiple gestation
• Rupture of membranes
• Taken a CYP3A4 inhibitor within 5 elimination half-lives of the drug from the procedure
• Pre-dosing abnormal liver function tests
• Patients at increased risk of hepatitis based on a history of any of the following:
• Any history of underlying liver disorder, including hepatitis
• A family history of hepatitis or currently living with a person 441 who has been given a diagnosis of hepatitis
• A history of or currently working as a sex worker
• A history of or currently using IV drugs
• A self-reported history of alcoholic dependency or abuse

Sponsors & Collaborators

• Sheba Medical Center: lead
• Stanford University: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 56506, Israel

Location

Related Publications (8)

• Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006714. doi: 10.1002/14651858.CD006714.pub2.

  PMID: 18254113 RESULT

• ACOG Practice Bulletin No. 135: Second-trimester abortion. Obstet Gynecol. 2013 Jun;121(6):1394-1406. doi: 10.1097/01.AOG.0000431056.79334.cc. No abstract available.

  PMID: 23812485 RESULT

• Borgatta L, Kapp N; Society of Family Planning. Clinical guidelines. Labor induction abortion in the second trimester. Contraception. 2011 Jul;84(1):4-18. doi: 10.1016/j.contraception.2011.02.005. Epub 2011 Mar 30.

  PMID: 21664506 RESULT

• Costescu D, Guilbert E. No. 360-Induced Abortion: Surgical Abortion and Second Trimester Medical Methods. J Obstet Gynaecol Can. 2018 Jun;40(6):750-783. doi: 10.1016/j.jogc.2017.12.010.

  PMID: 29861084 RESULT

• Li HWR, Gemzell-Danielsson K. Mechanisms of action of emergency contraception pills. Eur J Contracept Reprod Health Care. 2019 Feb;24(1):11-12. doi: 10.1080/13625187.2018.1555663. Epub 2019 Jan 21. No abstract available.

  PMID: 30664367 RESULT

• Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.

  PMID: 22296076 RESULT

• Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.

  PMID: 14667994 RESULT

• Meyer R, Toussia-Cohen S, Shats M, Segal O, Mohr-Sasson A, Peretz-Bookstein S, Amitai-Komem D, Sindel O, Levin G, Mashiach R, Blumenthal PD. 24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jul 1;144(1):60-67. doi: 10.1097/AOG.0000000000005535. Epub 2024 May 23.

  PMID: 38781593 DERIVED

Study Officials

• Aya A Mohr-Sasson, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: November 1, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

IL (1)