Second Trimester AbortionsNCT02363556
Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
A study testing Misoprostol administered vaginally, Misoprostol administered buccally and Misoprostol administered vaginally with Dilapan in people with Second Trimester Abortions, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
This randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to Dilation and Evacuations (D\&Es) at 14 0/7 to 19 6/7 weeks gestational age. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Trimester Abortions
- What is being tested?
- Misoprostol administered vaginally, Misoprostol administered buccally and Misoprostol administered vaginally with Dilapan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy pregnant women
- 18 years of age or older
- Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.
Who cannot join
- Women who do not speak English.
- Fetal demise
- Intolerance, allergy or contraindication to misoprostol or Dilapan.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood Metropolitan Washington
Silver Spring, Maryland, 20910
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Factorial-Design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-Day Cervical Preparation Prior to Dilation & Evacuation
This randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to Dilation and Evacuations (D\&Es) at 14 0/7 to 19 6/7 weeks gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with misoprostol and separately randomized to buccal or vaginal administration of 400-mcg misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40 buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and 40 buccal). Four to six hours later, the Dilation and Evacuation (D\&E) procedure will be performed.
Read the detailed description
The primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day Dilapan with 400-mcg misoprostol for cervical preparation prior to D\&E at 14 0/7 to 19 6/7 weeks. Patients will first be randomized to misoprostol alone or misoprostol-Dilapan, and then separately randomized to use the misoprostol buccally or vaginally.
The primary outcome measure is total procedure time. Secondary outcomes include D\&E procedure time, initial cervical dilation (measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction.
The investigators have chosen a randomized controlled trial with a factorial design to be conducted at Washington Hospital Center and Planned Parenthood of Metropolitan Washington. A total up to 180 English speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. The study will enroll healthy women, over the age of 18, eligible for non-urgent D\&E at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. The women will be randomized to receive either misoprostol alone or Dilapan with misoprostol. Women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. Computer generated randomization will be utilized to assign treatment arms. Approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations:
- Misoprostol 400-mcg vaginally
- Misoprostol 400-mcg buccally
- Dilapan insertion with 400-mcg misoprostol vaginally
- Dilapan insertion with 400-mcg misoprostol buccally
- Conditions
- Second Trimester Abortions
- Being tested
- Misoprostol administered vaginally, Misoprostol administered buccally, Misoprostol administered vaginally with Dilapan, Misoprostol administered buccally with Dilapan
- Keywords
- Cervical Dilation, Dilation and Evacuation, Misoprostol, Misoprostol-Dilapan, Abortion
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol administered vaginallyProcedure or surgery
Misoprostol administered buccallyProcedure or surgery
Misoprostol administered vaginally with DilapanProcedure or surgery
Misoprostol administered buccally with DilapanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol Alone | Experimental | Subjects enrolled into this arm of the study will receive misoprostol 400-mcg only. Receives: Procedure: Misoprostol administered vaginally; Procedure: Misoprostol administered buccally |
| Dilapan with Misoprostol | Experimental | Subjects enrolled into this arm of the study will receive Dilapan with 400-mcg misoprostol. Receives: Procedure: Misoprostol administered vaginally with Dilapan; Procedure: Misoprostol administered buccally with Dilapan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedure time
Total procedure time is defined as the time required for dilator insertion plus the D\&E time.
Measured: 4-6hrs
Secondary outcomes (2)
D&E procedure time
Measured: 0-60 mins
Initial cervical dilation
Measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure.
Measured: 0-10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Trimester AbortionsStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Matthew Reeves, Medstar Health Research Institute
- Investigators
- Dr. Matthew Reeves, MD MPH, Principal investigator, MedStar Washington Hospital Center & Planned Parenthood of Metropolitan WashingtonDr. Jamilah Shakir, MD MPH, Study chair, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363556
- Sponsor's protocol ID
- 2014-110
- Status last verified
- Aug 2017
- First submitted
- 3 Feb 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Factorial-Design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-Day Cervical Preparation Prior to Dilation & Evacuation
- ClinicalTrials.gov ID
- NCT02363556
- Acronym / sponsor ID
- 2014-110
- Conditions
- Second Trimester Abortions
- Keywords
- Cervical Dilation, Dilation and Evacuation, Misoprostol, Misoprostol-Dilapan, Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to Dilation and Evacuations (D\&Es) at 14 0/7 to 19 6/7 weeks gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with misoprostol and separately randomized to buccal or vaginal administration of 400-mcg misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40 buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and 40 buccal). Four to six hours later, the Dilation and Evacuation (D\&E) procedure will be performed.
Detailed description
The primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day Dilapan with 400-mcg misoprostol for cervical preparation prior to D\&E at 14 0/7 to 19 6/7 weeks. Patients will first be randomized to misoprostol alone or misoprostol-Dilapan, and then separately randomized to use the misoprostol buccally or vaginally.
The primary outcome measure is total procedure time. Secondary outcomes include D\&E procedure time, initial cervical dilation (measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction.
The investigators have chosen a randomized controlled trial with a factorial design to be conducted at Washington Hospital Center and Planned Parenthood of Metropolitan Washington. A total up to 180 English speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. The study will enroll healthy women, over the age of 18, eligible for non-urgent D\&E at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. The women will be randomized to receive either misoprostol alone or Dilapan with misoprostol. Women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. Computer generated randomization will be utilized to assign treatment arms. Approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations:
- Misoprostol 400-mcg vaginally
- Misoprostol 400-mcg buccally
- Dilapan insertion with 400-mcg misoprostol vaginally
- Dilapan insertion with 400-mcg misoprostol buccally
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol Alone | Experimental | Procedure: Misoprostol administered vaginally, Procedure: Misoprostol administered buccallySubjects enrolled into this arm of the study will receive misoprostol 400-mcg only. |
| Dilapan with Misoprostol | Experimental | Procedure: Misoprostol administered vaginally with Dilapan, Procedure: Misoprostol administered buccally with DilapanSubjects enrolled into this arm of the study will receive Dilapan with 400-mcg misoprostol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy pregnant women
- 18 years of age or older
- Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.
Key exclusion criteria (3 listed)
- Women who do not speak English.
- Fetal demise
- Intolerance, allergy or contraindication to misoprostol or Dilapan.
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 administered vaginally | Procedure or surgery | Misoprostol Alone |
| Misoprostol administered buccally | Procedure or surgery | Misoprostol Alone |
| Misoprostol administered vaginally with Dilapan | Procedure or surgery | Dilapan with Misoprostol |
| Misoprostol administered buccally with Dilapan | Procedure or surgery | Dilapan with Misoprostol |
Primary outcome
Total procedure time
Time frame: 4-6hrs
Total procedure time is defined as the time required for dilator insertion plus the D\&E time.
2 secondary outcomes
D&E procedure time
Time frame: 0-60 mins
Initial cervical dilation
Time frame: 0-10 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Second Trimester Abortions
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 4
Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Abortion, Dilation and Evacuation
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
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.
Dr. Matthew Reeves, MD MPH principal investigator
MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington
Dr. Jamilah Shakir, MD MPH study chair
Medstar Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol administered vaginally, Misoprostol administered buccally and Misoprostol administered vaginally with Dilapan in people with Second Trimester Abortions, run by Medstar Health Research Institute at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total procedure time (time frame: 4-6hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2017.