Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02342002
Other study ID # 1015
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 2015
Est. completion date December 31, 2018

Study information

Verified date November 2018
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.


Description:

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.


Recruitment information / eligibility

Status Terminated
Enrollment 416
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Ultrasound examination demonstrating:

1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR

2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.

- If fetus exists, fetal size less than 12 weeks+6 days

- Closed cervical os

- Eligible to consent for research according to local regulations

Exclusion Criteria:

- Active bleeding at enrollment and/or history of bleeding within the prior week

- Allergies or other contraindications to the use of mifepristone or misoprostol

- Suspected ectopic pregnancy

- History of trophoblastic disease

- Coagulation disorder and/or currently taking anticoagulants

- Any serious medical condition

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mifepristone
Mifepristone for treatment of missed abortion
Misoprostol
Misoprostol for treatment of missed abortion

Locations

Country Name City State
Argentina Hospital Nacional Profesor Alejandro Posadas Buenos Aires
Gabon CHU Libreville Libreville
Mexico Hospital General Valle Ceylan Tlalnepantla
Pakistan Agha Khan University Hospital Karachi

Sponsors (1)

Lead Sponsor Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Argentina,  Gabon,  Mexico,  Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of successful evacuation of the uterus uterine evacuation without the need for uterine aspiration or other surgery 1 week after treatment
Secondary Rate of successful evacuation without any additional intervention uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention 1 week after treatment
Secondary Excessive bleeding or a complication for which a woman received treatment 30 days after treatment
Secondary Induction expulsion interval after misoprostol administration time interval between misoprostol administration and the expulsion one week follow-up
Secondary Acceptability of assigned method to women one week follow-up
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A