Induced; Abortion, NonmedicalNCT01678703
Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
A study testing Laminaria, MedGyn Products, Inc. USA. and Misoprostol in people with Induced; Abortion, Nonmedical, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol. The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Induced; Abortion, Nonmedical
- What is being tested?
- Laminaria, MedGyn Products, Inc. USA. and Misoprostol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Jun 2010
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant patients with a viable singleton
- Pregnancy 14-20 weeks of gestation
- Admitted for termination of pregnancy
Who cannot join
- Contraindication for administration of Misoprostol
- Patients with more than one previous cesarean section scar
- Patients with impaired coagulation
- Significant pulmonary or cardiac disease
- Non viable pregnancy
- Placenta accreta or previa by ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.
The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.
The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.
Read the detailed description
This is a prospective randomized study.
The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.
Primary outcome measures will include:
Initial cervical opening and the need for further dilatation at the procedure Procedure duration
Difficulty score performing the abortion
Complications during and after the procedure
Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure
- Conditions
- Induced; Abortion, Nonmedical
- Being tested
- Laminaria, MedGyn Products, Inc. USA., Misoprostol
- Keywords
- late abortion, laminaria, Misoprostol, Cervical preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminaria, MedGyn Products, Inc. USA.Device
Also called laminaria tents
Insertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance.
MisoprostolDrug
Also called Cytotec
Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
| Study group | Role | What they receive |
|---|---|---|
| Laminaria group | Active comparator | Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion Receives: Device: Laminaria, MedGyn Products, Inc. USA. |
| Misoprostol group | Active comparator | Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial cervical opening and the need for further dilatation at the start of the procedure
The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol
Measured: 8-12 hours after insersion of laminaria or Misoprostol
Secondary outcomes (1)
pain score during cervical preparation and after the procedure
The pain score will be accessed immediately after the insertion of the laminaria or the vaginal Misoprostol.
Pain score will be recorded again right before performing the abortion and will address the 8-12 hours elapsed from the insertion.
Another assessment of pain will be recorded immediately after the abortion following recovery from general anesthesia
Measured: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startNov 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced; Abortion, NonmedicalStudies 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ron Sagiv, MD, Study director, Tel Aviv University, Sackler Medical School, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678703
- Sponsor's protocol ID
- 2trimabort.CTIL
- Status last verified
- Jul 2012
- First submitted
- 22 Aug 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT01678703
- Acronym / sponsor ID
- 2trimabort.CTIL
- Conditions
- Induced; Abortion, Nonmedical
- Keywords
- late abortion, laminaria, Misoprostol, Cervical preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Nov 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Sep 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.
This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.
The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.
The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.
Detailed description
This is a prospective randomized study.
The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.
Primary outcome measures will include:
Initial cervical opening and the need for further dilatation at the procedure Procedure duration
Difficulty score performing the abortion
Complications during and after the procedure
Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminaria group | Active comparator | Device: Laminaria, MedGyn Products, Inc. USA.Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion |
| Misoprostol group | Active comparator | Drug: MisoprostolPatients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant patients with a viable singleton
- Pregnancy 14-20 weeks of gestation
- Admitted for termination of pregnancy
Key exclusion criteria (6 listed)
- Contraindication for administration of Misoprostol
- Patients with more than one previous cesarean section scar
- Patients with impaired coagulation
- Significant pulmonary or cardiac disease
- Non viable pregnancy
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 |
|---|---|---|
| Laminaria, MedGyn Products, Inc. USA.Also: laminaria tentsInsertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance. | Device | Laminaria group |
| MisoprostolAlso: CytotecCervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion | Drug | Misoprostol group |
Primary outcome
Initial cervical opening and the need for further dilatation at the start of the procedure
Time frame: 8-12 hours after insersion of laminaria or Misoprostol
The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol
1 secondary outcome
pain score during cervical preparation and after the procedure
Time frame: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia
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 5 Sep 2012.
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.
Ron Sagiv, MD study director
Tel Aviv University, Sackler Medical School, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminaria, MedGyn Products, Inc. USA. and Misoprostol in people with Induced; Abortion, Nonmedical, run by Wolfson Medical Center at 1 site in Israel.
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 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 5 Sep 2012. 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 Israel. 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?
Initial cervical opening and the need for further dilatation at the start of the procedure (time frame: 8-12 hours after insersion of laminaria or Misoprostol). 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 5 Sep 2012.