Abortion, InducedNCT00495560
A Pilot Study of Priming Before Induction Termination of Pregnancy
A study testing Addition of misoprostol 25 mcg 12 hours before induction in people with Abortion, Induced and Abortion, Second Trimester, run by Boston University at 1 site in United States.
Trial summary
Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours from the start of medication (misoprostol) to expulsion of the fetus. The objective of this study is to evaluate a method of 'priming' on the length of induction termination of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced, Abortion, Second Trimester
- What is being tested?
- Addition of misoprostol 25 mcg 12 hours before induction
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2007
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age or over
- able to give informed consent in English or Spanish
- requesting termination of pregnancy
- pregnancy 18-23 weeks of gestation
Who cannot join
- Unable to understand and give informed consent
- Under 18 years of age
- Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment
- Ruptured membranes or signs of infection (temperature over 100.6 F,WBC >15K)
- Fetal demise, Multi-fetal pregnancy contraindication to misoprostol
- contraindication to misoprostol
Trial locations and contacts
1 site in 1 country.
About this study
Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours from the start of medication (misoprostol) to expulsion of the fetus. The objective of this study is to evaluate a method of 'priming' on the length of induction termination of pregnancy. "Priming" refers to the use of medication to ready the cervix and uterus so that the uterus is more sensitive to medication and contracts more effectively, and also refers to softening of the cervix so that there is less resistance to dilation. Priming is used extensively before induction of labor for term pregnancy and is also used extensively before surgical abortion in second trimester. We would like to add priming the evening before induction to the usual treatment and evaluate whether the length of the induction process is shortened. Women are admitted to the hospital in the morning to start misoprostol medication, and unless expulsion occurs within 8-10 hours, need to stay overnight.
The study design is to give the priming dose 12 hours before admission. The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus.
This study aims to assess whether the use of misoprostol as a priming agent would be beneficial with women who undergo induction termination of pregnancy.
Read the detailed description
This is a prospective series. All women enrolled will receive the same treatment. 10 women without prior births and 10 women with prior births will be enrolled. The study design is to give the priming dose 12 hours before admission.
The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus.
Inclusion criteria: Women who have requested induction abortion and completed the counseling and consent process for abortion. Women 18 years of age or over. Capable of giving informed consent. Speak English or Spanish Pregnancy 18-23 weeks. No contraindication to misoprostol abortion
Exclusion criteria: Unable to understand and give informed consent. Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment. Ruptured membranes or signs of infection (temperature over 100.6 F,WBC >15K) Fetal demise Multi-fetal pregnancy Contraindication to any of the agents used for misoprostol induction abortion
After women have started the abortion process (completed counseling and consent for abortion, and completed the fetocidal digoxin injection), they will be approached by one of the investigators. The procedures and the consent process will be explained. If they consent, they will be given an envelope which contains 50 mcg of misoprostol (1/2 of a 100 mcg tablet). They will be instructed to place the tablet buccally and hold it in place for 30 minutes, after which it can be swallowed, between 8 and 9 pm that evening.
They will return at 7 am the next morning; the actual induction process starts between 8 and 10 am depending on the bed situation. The reminder of the care is identical to women not in the study and consists of misoprostol 400 every 6 hours. The only step that will be from the current induction process is the administration of the priming dose the night before.
The duration of participation for individuals is up to 48 hours. The study overall will take one year.
Analytic plan:
This is a pilot study to estimate the effect on induction times, and to monitor for any adverse events. This pilot will be the basis of further study.
When the sample size is 19, a two-sided 95.0% confidence interval for a single mean will have an interval that extends no more than 1.5 from the observed mean, assuming that the true standard deviation is 3.25 and that the confidence interval is based on the t statistic. The "typical" mean is 14 hours and the 95% confidence interval around 12.5 hours is 11hours to 14 hours.
The primary outcome is the induction time, the time from start of induction until fetal expulsion. As there are about 80 induction procedures per year, and past studies have enrolled 50-60% of eligible women, it will take approximately 6 months to complete enrollment.
The length of induction will be described and the mean will be contrasted to a typical value (14 hours) . Minor events such as nausea will be tabulated. There will be a sub-analysis of outcome by parity (women without prior births compared to women with prior births). This study is not powered to show differences between these two groups but this information wil be helpful in planning future studies.
- Conditions
- Abortion, Induced, Abortion, Second Trimester
- Being tested
- Addition of misoprostol 25 mcg 12 hours before induction
- Keywords
- induction, abortion, injection, intra-amniotic, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of misoprostol 25 mcg 12 hours before inductionDrug
Misoprostol given buccally the night before induction
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time between the start and the finish of the induction
Measured: 24 h
Secondary outcomes (1)
incidence of nausea and cramping
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2007
- Study completionJul 2007
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Investigators
- Nilda L Moreno-Ruiz, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495560
- Sponsor's protocol ID
- 26135
- Status last verified
- Oct 2008
- First submitted
- 29 Jun 2007
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Priming Before Induction Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT00495560
- Acronym / sponsor ID
- 26135
- Conditions
- Abortion, Induced, Abortion, Second Trimester
- Keywords
- induction, abortion, injection, intra-amniotic, misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Jul 2007 (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.
Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours from the start of medication (misoprostol) to expulsion of the fetus. The objective of this study is to evaluate a method of 'priming' on the length of induction termination of pregnancy. "Priming" refers to the use of medication to ready the cervix and uterus so that the uterus is more sensitive to medication and contracts more effectively, and also refers to softening of the cervix so that there is less resistance to dilation. Priming is used extensively before induction of labor for term pregnancy and is also used extensively before surgical abortion in second trimester. We would like to add priming the evening before induction to the usual treatment and evaluate whether the length of the induction process is shortened. Women are admitted to the hospital in the morning to start misoprostol medication, and unless expulsion occurs within 8-10 hours, need to stay overnight.
The study design is to give the priming dose 12 hours before admission. The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus.
This study aims to assess whether the use of misoprostol as a priming agent would be beneficial with women who undergo induction termination of pregnancy.
Detailed description
This is a prospective series. All women enrolled will receive the same treatment. 10 women without prior births and 10 women with prior births will be enrolled. The study design is to give the priming dose 12 hours before admission.
The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus.
Inclusion criteria: Women who have requested induction abortion and completed the counseling and consent process for abortion. Women 18 years of age or over. Capable of giving informed consent. Speak English or Spanish Pregnancy 18-23 weeks. No contraindication to misoprostol abortion
Exclusion criteria: Unable to understand and give informed consent. Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment. Ruptured membranes or signs of infection (temperature over 100.6 F,WBC >15K) Fetal demise Multi-fetal pregnancy Contraindication to any of the agents used for misoprostol induction abortion
After women have started the abortion process (completed counseling and consent for abortion, and completed the fetocidal digoxin injection), they will be approached by one of the investigators. The procedures and the consent process will be explained. If they consent, they will be given an envelope which contains 50 mcg of misoprostol (1/2 of a 100 mcg tablet). They will be instructed to place the tablet buccally and hold it in place for 30 minutes, after which it can be swallowed, between 8 and 9 pm that evening.
They will return at 7 am the next morning; the actual induction process starts between 8 and 10 am depending on the bed situation. The reminder of the care is identical to women not in the study and consists of misoprostol 400 every 6 hours. The only step that will be from the current induction process is the administration of the priming dose the night before.
The duration of participation for individuals is up to 48 hours. The study overall will take one year.
Analytic plan:
This is a pilot study to estimate the effect on induction times, and to monitor for any adverse events. This pilot will be the basis of further study.
When the sample size is 19, a two-sided 95.0% confidence interval for a single mean will have an interval that extends no more than 1.5 from the observed mean, assuming that the true standard deviation is 3.25 and that the confidence interval is based on the t statistic. The "typical" mean is 14 hours and the 95% confidence interval around 12.5 hours is 11hours to 14 hours.
The primary outcome is the induction time, the time from start of induction until fetal expulsion. As there are about 80 induction procedures per year, and past studies have enrolled 50-60% of eligible women, it will take approximately 6 months to complete enrollment.
The length of induction will be described and the mean will be contrasted to a typical value (14 hours) . Minor events such as nausea will be tabulated. There will be a sub-analysis of outcome by parity (women without prior births compared to women with prior births). This study is not powered to show differences between these two groups but this information wil be helpful in planning future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years of age or over
- able to give informed consent in English or Spanish
- requesting termination of pregnancy
- pregnancy 18-23 weeks of gestation
Key exclusion criteria (6 listed)
- Unable to understand and give informed consent
- Under 18 years of age
- Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment
- Ruptured membranes or signs of infection (temperature over 100.6 F,WBC >15K)
- Fetal demise, Multi-fetal pregnancy contraindication 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 |
|---|---|---|
| Addition of misoprostol 25 mcg 12 hours before inductionMisoprostol given buccally the night before induction | Drug | – |
Primary outcome
Length of time between the start and the finish of the induction
Time frame: 24 h
1 secondary outcome
incidence of nausea and cramping
Time frame: 24 h
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 7 Oct 2008.
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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.
Nilda L Moreno-Ruiz, MD principal investigator
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 Addition of misoprostol 25 mcg 12 hours before induction in people with Abortion, Induced and Abortion, Second Trimester, 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 6 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 7 Oct 2008. 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?
Length of time between the start and the finish of the induction (time frame: 24 h). 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 7 Oct 2008.