Abortion, InducedNCT02279914
Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
A study testing Misoprostol 400 mcg 3 hours prior to procedure and Misoprostol 600 mcg 90 minutes prior to procedure in people with Abortion, Induced, run by Planned Parenthood of Greater New York at 1 site in United States.
Trial summary
This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E. 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
- Abortion, Induced
- What is being tested?
- Misoprostol 400 mcg 3 hours prior to procedure and Misoprostol 600 mcg 90 minutes prior to procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- 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
- 18 years of age and older
- Eligible for pregnancy termination at Planned Parenthood of NYC
- Able to give informed consent
- English speaking
Who cannot join
- Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
- Intrauterine fetal demise identified on pre-operative ultrasound
- Allergy to misoprostol
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood of New York City - Margaret Sanger Center
New York, New York, 10012
About this study
This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E.
Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.
Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability
Read the detailed description
The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.
- Conditions
- Abortion, Induced
- Being tested
- Misoprostol 400 mcg 3 hours prior to procedure, Misoprostol 600 mcg 90 minutes prior to procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 400 mcg 3 hours prior to procedureDrug
Misoprostol 400 mcg 3 hours prior to D\&E procedure
Misoprostol 600 mcg 90 minutes prior to procedureDrug
Misoprostol 600 mcg 90 minutes prior to D\&E procedure
| Study group | Role | What they receive |
|---|---|---|
| 400 mcg | Experimental | receives 400 mcg of misoprostol 3 hours prior to the procedure Receives: Drug: Misoprostol 400 mcg 3 hours prior to procedure |
| 600 mcg | Experimental | receives 600 mcg of misoprostol 90 minutes prior to the procedure Receives: Drug: Misoprostol 600 mcg 90 minutes prior to procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time
Operative time defined as time from speculum in vagina to speculum out of vagina.
Measured: day of abortion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, InducedStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood of Greater New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Dean, MD, MPH, Principal investigator, Planned Parenthood of NYC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279914
- Sponsor's protocol ID
- Miso
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2014
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02279914
- Acronym / sponsor ID
- Miso
- Conditions
- Abortion, Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Planned Parenthood of Greater New YorkUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 Oct 2014 (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 study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E.
Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.
Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability
Detailed description
The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 mcg | Experimental | Drug: Misoprostol 400 mcg 3 hours prior to procedurereceives 400 mcg of misoprostol 3 hours prior to the procedure |
| 600 mcg | Experimental | Drug: Misoprostol 600 mcg 90 minutes prior to procedurereceives 600 mcg of misoprostol 90 minutes prior to the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- Eligible for pregnancy termination at Planned Parenthood of NYC
- Able to give informed consent
- English speaking
Key exclusion criteria (3 listed)
- Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
- Intrauterine fetal demise identified on pre-operative ultrasound
- Allergy to misoprostol
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 400 mcg 3 hours prior to procedureMisoprostol 400 mcg 3 hours prior to D\&E procedure | Drug | 400 mcg |
| Misoprostol 600 mcg 90 minutes prior to procedureMisoprostol 600 mcg 90 minutes prior to D\&E procedure | Drug | 600 mcg |
Primary outcome
procedure time
Time frame: day of abortion procedure
Operative time defined as time from speculum in vagina to speculum out of vagina.
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 26 Apr 2021.
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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.
Gillian Dean, MD, MPH principal investigator
Planned Parenthood of NYC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol 400 mcg 3 hours prior to procedure and Misoprostol 600 mcg 90 minutes prior to procedure in people with Abortion, Induced, run by Planned Parenthood of Greater New York 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 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 26 Apr 2021. 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?
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?
procedure time (time frame: day of abortion procedure). 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 26 Apr 2021.