Early Pregnancy FailureMiMiNCT00468299

MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure

A study testing Mifepristone and misoprostol in people with Early Pregnancy Failure and Miscarriage, run by Boston University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. Read more about this study

Who is it for?: Ages 18 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Early Pregnancy Failure, Miscarriage, Fetal Demise
What is being tested?: Mifepristone and misoprostol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Apr 2007to Dec 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Age >18yrs, able to read and write English
Intrauterine gestations with anembryonic sac between 10 and 45mm or
10-15mm sac with no growth in three days or other radiologic signs of abnormal pregnancy such as irregular sac or debris within the gestational sac
An embryonic pole <30mm with no cardiac activity

Who cannot join

Intrauterine gestations with CRL <5mm or >30mm without cardiac activity
Incomplete abortion as defined as open cervix and large amount of cramping/bleeding
Hemodynamic instability and/or heavy vaginal bleeding
Hemoglobin less than or equal to 8
Inability to follow-up (ie, lack of transportation or access to telephone)
Bleeding disorder or taking anticoagulants

Show all 12Show fewer

Prior medical or surgical treatment of the current pregnancy
Obvious Infection
Active Lactation
Allergy to mifepristone or misoprostol
Chronic corticosteroid use
Severe gastrointestinal disease (e.g inflammatory bowel disease, severe gastritis)

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston University
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Treatment of Early Pregnancy Failure

Read the detailed description

The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated efficacy at one week. We have found that many women do not want to wait for one week for an outcome of their medical treatment, and want resolution sooner. This has hampered the widespread utilization of medical therapy in our institution.

We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to demonstrate the relative efficacy of two medication regimens for treatment of EPF by performing a randomized trial. One regimen will be 800μg buccal misoprostol alone and the other regimen will be 200mg mifepristone, orally, in addition to 800μg buccal misoprostol, simultaneously. The primary outcome will be complete abortion rates 24hours after medication administration. We hypothesize that mifepristone will not improve complete abortion rates at 24hrs.

Secondary outcomes include rates of abortion by medical treatment at one week, the indications for surgical intervention, relationship of progesterone levels and type of pregnancy failure to outcomes in the two groups. Another secondary objective is to assess satisfaction with the treatment process at the conclusion of pregnancy termination, and 3 weeks after the beginning of the process.

The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but buccal use is increasing. We will use buccal misoprostol, which is widely used at our institution. We will assess the efficacy of this route of administration as well as assess patient acceptability of this method.

Conditions: Early Pregnancy Failure, Miscarriage, Fetal Demise, Anembryonic Pregnancy
Being tested: Misoprostol and placebo, Mifepristone and misoprostol
Keywords: early, pregnancy, failure, mifepristone, misoprostol, buccal, miscarriage, fetal, demise, anembryonic, progesterone
Medical subject headings: Abortion, Spontaneous, Fetal Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Misoprostol and placeboDrug
Women in this group receive 800 mcg misoprostol plus a placebo
Mifepristone and misoprostolDrug
This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally

Study groups in NCT00468299
Study group	Role	What they receive
Misoprostol and placebo	Active comparator	Women in this arm receive placebo and misoprostol 800 mcg buccally Receives: Drug: Misoprostol and placebo
Mifepristone and misoprostol	Experimental	Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally Receives: Drug: Mifepristone and misoprostol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.
Measured: 24-48 hrs

Secondary outcomes (1)

Complete Abortion at One Week
Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Dec 2008

First posted2 May 2007 (estimated)
Study startApr 2007
Primary completionDec 2008
Study completionDec 2008

Why it stopped: poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Early Pregnancy FailureStudies of the same condition, open and under way.
More trials run by Boston UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00468299
Sponsor's protocol ID: H-25999
Acronym: MiMi
Status last verified: Jun 2011
First submitted: 1 May 2007
Last updated: 21 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. doi: 10.1093/humrep/deh049.
PubMed 14747165
Creinin MD, Schwartz JL, Guido RS, Pymar HC. Early pregnancy failure--current management concepts. Obstet Gynecol Surv. 2001 Feb;56(2):105-13. doi: 10.1097/00006254-200102000-00024.
PubMed 11219590
Lelaidier C, Saint-Mleux CB, Fernandez H, Bourget P, Frydman R. [Embryo expulsion induction in first trimester miscarriages. Use of mifepristone (RU 486) in a double blind prospective randomized study]. Contracept Fertil Sex. 1993 Jun;21(6):505-8. French.
PubMed 7920940
Lister MS, Shaffer LE, Bell JG, Lutter KQ, Moorma KH. Randomized, double-blind, placebo-controlled trial of vaginal misoprostol for management of early pregnancy failures. Am J Obstet Gynecol. 2005 Oct;193(4):1338-43. doi: 10.1016/j.ajog.2005.05.010.
PubMed 16202723
Meckstroth KR, Whitaker AK, Bertisch S, Goldberg AB, Darney PD. Misoprostol administered by epithelial routes: Drug absorption and uterine response. Obstet Gynecol. 2006 Sep;108(3 Pt 1):582-90. doi: 10.1097/01.AOG.0000230398.32794.9d.
PubMed 16946218
Middleton T, Schaff E, Fielding SL, Scahill M, Shannon C, Westheimer E, Wilkinson T, Winikoff B. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception. 2005 Nov;72(5):328-32. doi: 10.1016/j.contraception.2005.05.017. Epub 2005 Aug 9.
PubMed 16246656
Nielsen S, Hahlin M, Platz-Christensen JJ. Unsuccessful treatment of missed abortion with a combination of an antiprogesterone and a prostaglandin E1 analogue. Br J Obstet Gynaecol. 1997 Sep;104(9):1094-6. doi: 10.1111/j.1471-0528.1997.tb12075.x.
PubMed 9307543
Schaff EA, DiCenzo R, Fielding SL. Comparison of misoprostol plasma concentrations following buccal and sublingual administration. Contraception. 2005 Jan;71(1):22-5. doi: 10.1016/j.contraception.2004.06.014.
PubMed 15639067
Stockheim D, Machtinger R, Wiser A, Dulitzky M, Soriano D, Goldenberg M, Schiff E, Seidman DS. A randomized prospective study of misoprostol or mifepristone followed by misoprostol when needed for the treatment of women with early pregnancy failure. Fertil Steril. 2006 Oct;86(4):956-60. doi: 10.1016/j.fertnstert.2006.03.032.
PubMed 17027362
Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.
PubMed 11821273
Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.
PubMed 16707509
Wagaarachchi PT, Ashok PW, Smith NC, Templeton A. Medical management of early fetal demise using sublingual misoprostol. BJOG. 2002 Apr;109(4):462-5. doi: 10.1111/j.1471-0528.2002.01075.x.
PubMed 12013170
Wagaarachchi PT, Ashok PW, Narvekar N, Smith NC, Templeton A. Medical management of early fetal demise using a combination of mifepristone and misoprostol. Hum Reprod. 2001 Sep;16(9):1849-53. doi: 10.1093/humrep/16.9.1849.
PubMed 11527887
Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM; National Institute of Child Health Human Development (NICHD) Management of Early Pregnancy Failure Trial. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005 Aug 25;353(8):761-9. doi: 10.1056/NEJMoa044064.
PubMed 16120856
Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.
PubMed 9207820

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Early Pregnancy Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Early Pregnancy Failure
ClinicalTrials.gov ID: NCT00468299
Acronym / sponsor ID: MiMi / H-25999
Conditions: Early Pregnancy Failure, Miscarriage, Fetal Demise, Anembryonic Pregnancy
Keywords: early, pregnancy, failure, mifepristone, misoprostol, buccal, miscarriage, fetal
Study type: Interventional
Recruitment status: TerminatedReason stopped: poor enrollment
Enrolment: 16 participants (actual)
Lead sponsor: Boston UniversityUniversity, hospital or other
Study start: Apr 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 2 May 2007 (estimated)
Results: Posted 21 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Misoprostol and placebo	Active comparator	Drug: Misoprostol and placeboWomen in this arm receive placebo and misoprostol 800 mcg buccally
Mifepristone and misoprostol	Experimental	Drug: Mifepristone and misoprostolWomwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally

Who may qualify

Ages: 18 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age >18yrs, able to read and write English
Intrauterine gestations with anembryonic sac between 10 and 45mm or
10-15mm sac with no growth in three days or other radiologic signs of abnormal pregnancy such as irregular sac or debris within the gestational sac
An embryonic pole <30mm with no cardiac activity

Key exclusion criteria (12 listed)

Intrauterine gestations with CRL <5mm or >30mm without cardiac activity
Incomplete abortion as defined as open cervix and large amount of cramping/bleeding
Hemodynamic instability and/or heavy vaginal bleeding
Hemoglobin less than or equal to 8
Inability to follow-up (ie, lack of transportation or access to telephone)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Misoprostol and placeboWomen in this group receive 800 mcg misoprostol plus a placebo	Drug	Misoprostol and placebo
Mifepristone and misoprostolThis group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally	Drug	Mifepristone and misoprostol

Primary outcome

Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.
Time frame: 24-48 hrs

1 secondary outcome

Complete Abortion at One Week
Time frame: 3 weeks

Results and safety

Results posted to the registry on 21 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Misoprostol and Placebo	9	9
Mifepristone and Misoprostol	8	7

Primary outcome: Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.

Time frame: 24-48 hrs. Number. Unit: participants

Measure	Misoprostol and Placebo n = 9	Mifepristone and Misoprostol n = 8
Value	5	5

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Misoprostol and Placebo	0 of 9 (0%)	0 of 9 (0%)	Not reported
Mifepristone and Misoprostol	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated because of poor enrollment. Few eligible women were referred.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14747165Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. doi: 10.1093/humrep/deh049.
Background: PubMed 11219590Creinin MD, Schwartz JL, Guido RS, Pymar HC. Early pregnancy failure--current management concepts. Obstet Gynecol Surv. 2001 Feb;56(2):105-13. doi: 10.1097/00006254-200102000-00024.
Background: PubMed 7920940Lelaidier C, Saint-Mleux CB, Fernandez H, Bourget P, Frydman R. [Embryo expulsion induction in first trimester miscarriages. Use of mifepristone (RU 486) in a double blind prospective randomized study]. Contracept Fertil Sex. 1993 Jun;21(6):505-8. French.
Background: PubMed 16202723Lister MS, Shaffer LE, Bell JG, Lutter KQ, Moorma KH. Randomized, double-blind, placebo-controlled trial of vaginal misoprostol for management of early pregnancy failures. Am J Obstet Gynecol. 2005 Oct;193(4):1338-43. doi: 10.1016/j.ajog.2005.05.010.
Background: PubMed 16946218Meckstroth KR, Whitaker AK, Bertisch S, Goldberg AB, Darney PD. Misoprostol administered by epithelial routes: Drug absorption and uterine response. Obstet Gynecol. 2006 Sep;108(3 Pt 1):582-90. doi: 10.1097/01.AOG.0000230398.32794.9d.
Background: PubMed 16246656Middleton T, Schaff E, Fielding SL, Scahill M, Shannon C, Westheimer E, Wilkinson T, Winikoff B. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception. 2005 Nov;72(5):328-32. doi: 10.1016/j.contraception.2005.05.017. Epub 2005 Aug 9.
Background: PubMed 9307543Nielsen S, Hahlin M, Platz-Christensen JJ. Unsuccessful treatment of missed abortion with a combination of an antiprogesterone and a prostaglandin E1 analogue. Br J Obstet Gynaecol. 1997 Sep;104(9):1094-6. doi: 10.1111/j.1471-0528.1997.tb12075.x.
Background: PubMed 15639067Schaff EA, DiCenzo R, Fielding SL. Comparison of misoprostol plasma concentrations following buccal and sublingual administration. Contraception. 2005 Jan;71(1):22-5. doi: 10.1016/j.contraception.2004.06.014.
Background: PubMed 17027362Stockheim D, Machtinger R, Wiser A, Dulitzky M, Soriano D, Goldenberg M, Schiff E, Seidman DS. A randomized prospective study of misoprostol or mifepristone followed by misoprostol when needed for the treatment of women with early pregnancy failure. Fertil Steril. 2006 Oct;86(4):956-60. doi: 10.1016/j.fertnstert.2006.03.032.
Background: PubMed 11821273Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.
Background: PubMed 16707509Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.
Background: PubMed 12013170Wagaarachchi PT, Ashok PW, Smith NC, Templeton A. Medical management of early fetal demise using sublingual misoprostol. BJOG. 2002 Apr;109(4):462-5. doi: 10.1111/j.1471-0528.2002.01075.x.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah J Betstadt, MD principal investigator

Boston University

Olivera Vragovic, MBA study director

Boston University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mifepristone and misoprostol in people with Early Pregnancy Failure and Miscarriage, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. (time frame: 24-48 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00468299, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.