Abortion, InducedNCT01597726
Cervical Priming Before Dilation & Evacuation
A study testing Misoprostol and Laminaria in people with Abortion, Induced, run by Ibis Reproductive Health at 1 site in South Africa.
Trial summary
The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D\&E at 13-20 weeks gestation in the Western Cape Province, South Africa Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- Misoprostol and Laminaria
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2012to Jun 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman seeking TOP between 13 and 20 weeks gestation as determined by ultrasound
- Age 18 or greater
- Willingness to participate in randomized study
- Fluency in English, Afrikaans or Xhosa
- Ability to give informed consent
- Staying within one hour travel time of Tygerberg Hospital for the night prior to the D\&E
- Ability to be contacted by telephone
Who cannot join
- Active cervicitis
- Multiple gestation
- Fetal demise confirmed by ultrasound examination
- History of bleeding disorder or current anticoagulation therapy
- Allergy to misoprostol
- Currently breastfeeding and unwilling or unable to temporarily discard milk
- More than one prior cesarean delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial
The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D\&E at 13-20 weeks gestation in the Western Cape Province, South Africa
Read the detailed description
As misoprostol is increasingly being used for cervical preparation, concerns about its use and about the proportion of women expelling the fetus prior to the D\&E and other side effects mean that rigorous data on possible advantages of osmotic dilators are needed. To address this gap in the literature, we propose to perform an RCT comparing two methods of cervical preparation prior to D\&E:
- Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose (a modified version of the current protocol)
- Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E
- Conditions
- Abortion, Induced
- Being tested
- Misoprostol, Laminaria
- Keywords
- Abortion, Induced, Laminaria, Misoprostol, Pregnancy Trimester, Second
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose if needed
LaminariaDevice
Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | Not described Receives: Drug: Misoprostol |
| Laminaria | Experimental | Not described Receives: Device: Laminaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with fetal expulsion prior to dilation and evacuation
Measured: Prior to D&E procedure
Secondary outcomes (4)
Proportion of women requiring additional dilation (manual or pharmacologic)
Measured: At time of D&E procedure
Duration of dilation and evacuation procedure
Measured: End of D&E procedure
Frequency of major complications
Major complications to include:
- Death
- Admission to the ward after the procedure
- Readmission after discharge
- Abdominal surgical procedure
- Suspected uterine perforation
- Seizure
- Hemorrhage requiring transfusion
- Loss to follow-up after placement of laminaria
Measured: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)
Frequency of Minor Complications
Minor complications to include:
- Hemorrhage not requiring transfusion
- Infection requiring outpatient treatment
- Trauma to cervix or vagina
- Transfer to another facility to complete the procedure
- Need for repeat surgical evacuation of the uterus
Measured: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibis Reproductive Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, Tygerberg Hospital, Safe Abortion Action Fund of the International Planned Parenthood Federation, Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Judy Kluge, MBChB, Principal investigator, Tygerberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597726
- Sponsor's protocol ID
- 32020
- Status last verified
- Nov 2013
- First submitted
- 10 May 2012
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Constant D, Kluge J, Harries J, Grossman D. An analysis of delays among women accessing second-trimester abortion in the public sector in South Africa. Contraception. 2019 Sep;100(3):209-213. doi: 10.1016/j.contraception.2019.04.009. Epub 2019 Apr 25.
PubMed 31029655Grossman D, Constant D, Lince-Deroche N, Harries J, Kluge J. A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa. Contraception. 2014 Sep;90(3):234-41. doi: 10.1016/j.contraception.2014.05.003. Epub 2014 May 14.
PubMed 24929888
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01597726
- Acronym / sponsor ID
- 32020
- Conditions
- Abortion, Induced
- Keywords
- Abortion, Induced, Laminaria, Misoprostol, Pregnancy Trimester, Second
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ibis Reproductive HealthUniversity, hospital or other
- Collaborators
- University of Cape Town, Tygerberg Hospital, Safe Abortion Action Fund of the International Planned Parenthood Federation, Society of Family Planning
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 May 2012 (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.
The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D\&E at 13-20 weeks gestation in the Western Cape Province, South Africa
Detailed description
As misoprostol is increasingly being used for cervical preparation, concerns about its use and about the proportion of women expelling the fetus prior to the D\&E and other side effects mean that rigorous data on possible advantages of osmotic dilators are needed. To address this gap in the literature, we propose to perform an RCT comparing two methods of cervical preparation prior to D\&E:
- Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose (a modified version of the current protocol)
- Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: Misoprostol |
| Laminaria | Experimental | Device: Laminaria |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Woman seeking TOP between 13 and 20 weeks gestation as determined by ultrasound
- Age 18 or greater
- Willingness to participate in randomized study
- Fluency in English, Afrikaans or Xhosa
- Ability to give informed consent
Key exclusion criteria (7 listed)
- Active cervicitis
- Multiple gestation
- Fetal demise confirmed by ultrasound examination
- History of bleeding disorder or current anticoagulation therapy
- 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 |
|---|---|---|
| MisoprostolMisoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose if needed | Drug | Misoprostol |
| LaminariaLaminaria tents inserted into the cervix 18 to 24 hours prior to D\&E | Device | Laminaria |
Primary outcome
Proportion of women with fetal expulsion prior to dilation and evacuation
Time frame: Prior to D&E procedure
4 secondary outcomes
Proportion of women requiring additional dilation (manual or pharmacologic)
Time frame: At time of D&E procedure
Duration of dilation and evacuation procedure
Time frame: End of D&E procedure
Frequency of major complications
Time frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)
Frequency of Minor Complications
Time frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)
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 Nov 2013.
- Derived from this study: PubMed 31029655Constant D, Kluge J, Harries J, Grossman D. An analysis of delays among women accessing second-trimester abortion in the public sector in South Africa. Contraception. 2019 Sep;100(3):209-213. doi: 10.1016/j.contraception.2019.04.009. Epub 2019 Apr 25.
- Derived from this study: PubMed 24929888Grossman D, Constant D, Lince-Deroche N, Harries J, Kluge J. A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa. Contraception. 2014 Sep;90(3):234-41. doi: 10.1016/j.contraception.2014.05.003. Epub 2014 May 14.
- Click here to visit the Ibis Reproductive Health websiteLink provided by the sponsor.
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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.
Judy Kluge, MBChB principal investigator
Tygerberg Hospital
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 and Laminaria in people with Abortion, Induced, run by Ibis Reproductive Health at 1 site in South Africa.
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 7 inclusion and 7 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 Nov 2013. 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 South Africa. 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?
Proportion of women with fetal expulsion prior to dilation and evacuation (time frame: Prior to D&E procedure). 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 NCT01597726, which also lists 2 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 7 Nov 2013.