Pregnancy Trimester, SecondPhase 4NCT03106389
Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy
A Phase 4 study testing Misoprostol and Misoprostol/Transcervical catheter in people with Pregnancy Trimester, Second and Misoprostol, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This randomized controlled study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Trimester, Second, Misoprostol, Catheters
- What is being tested?
- Misoprostol and Misoprostol/Transcervical catheter
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 31 Jul 2017
- Phase
- Phase 4
- 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
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo Governorate, Cairo Governorate, 11591
Alaa Elfeky, Professor, +201222157568, aelfeky@gmail.com
About this study
Official title: Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy: A Randomized Controlled Trial
This randomized controlled study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation).
Read the detailed description
The study will be conducted at Ain Shams Maternity Hospital. An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive the standard misoprostol protocol for termination of second trimester pregnancy currently practiced at Ain Shams Maternity Hospital; 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours till complete expulsion of the uterine contents or surgical interference is decided. The second group will receive the exact same regimen, but will have in addition a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; and will have weighted traction applied to the catheter through using a 1000 ml fluid-filled bag in order to apply continuous pressure to the cervix. The target sample size was calculated to be 108 cases; randomization will be in a ratio of 1:1 using a computer-generated random sequence. Allocation will be concealed using sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will thus be randomly assigned to one of the groups.
- Being tested
- Misoprostol, Misoprostol/Transcervical catheter
- Keywords
- misoprostol, transcervical balloon catheter, second trimester, induced abortion
- 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
Also called Cytotec, Misotac
400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion
Misoprostol/Transcervical catheterDevice
Also called Foley catheter
Foleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | This group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. Receives: Drug: Misoprostol |
| Misoprostol/Transcervical catheter | Experimental | This group will receive the same regimen, but will have in addition a transcervical balloon (Foleys') catheter that is inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix Receives: Drug: Misoprostol; Device: Misoprostol/Transcervical catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction-expulsion interval
The duration from the administration of the first misoprostol dose vaginally till complete expulsion of the uterine contents; complete uterine emptiness will be confirmed by ultrasonographic assessment
Measured: 48 hours from starting intervention
Secondary outcomes (2)
Total required doses of misoprostol
The total amount of misoprostol used per participant during the procedure
Measured: 48 hours from starting induction
The need for surgical interventions
The number of participants requiring any surgical intervention under anesthesia to complete uterine emptiness
Measured: 1 week from starting induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Mar 2017
- Primary completion30 Jun 2017 (estimated)
- Study completion31 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Trimester, SecondStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. The second group will receive the same regimen, but in addition will have a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix. The target sample size is 108 cases randomized in a ratio of 1:1 using a computer-generated random sequence, allocation will be concealed in sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will be randomly assigned to one of the two groups.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Elfeky, Ain Shams Maternity Hospital
- Investigators
- Alaa Elfeky, Professor, Principal investigator, AinShams University Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106389
- Sponsor's protocol ID
- OBINTVN1
- Status last verified
- May 2017
- First submitted
- 3 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after publication of the study upon formal request by researchers and research centers that collaborate with Ain Shams Maternity Hospital. Data could be obtained through contacting PI by email.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03106389
- Acronym / sponsor ID
- OBINTVN1
- Keywords
- misoprostol, transcervical balloon catheter, second trimester, induced abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 31 Jul 2017 (estimated)
- First posted
- 10 Apr 2017 (actual)
- 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 study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation).
Detailed description
The study will be conducted at Ain Shams Maternity Hospital. An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive the standard misoprostol protocol for termination of second trimester pregnancy currently practiced at Ain Shams Maternity Hospital; 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours till complete expulsion of the uterine contents or surgical interference is decided. The second group will receive the exact same regimen, but will have in addition a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; and will have weighted traction applied to the catheter through using a 1000 ml fluid-filled bag in order to apply continuous pressure to the cervix. The target sample size was calculated to be 108 cases; randomization will be in a ratio of 1:1 using a computer-generated random sequence. Allocation will be concealed using sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will thus be randomly assigned to one of the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. The second group will receive the same regimen, but in addition will have a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix. The target sample size is 108 cases randomized in a ratio of 1:1 using a computer-generated random sequence, allocation will be concealed in sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will be randomly assigned to one of the two groups.
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: MisoprostolThis group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. |
| Misoprostol/Transcervical catheter | Experimental | Drug: Misoprostol, Device: Misoprostol/Transcervical catheterThis group will receive the same regimen, but will have in addition a transcervical balloon (Foleys') catheter that is inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MisoprostolAlso: Cytotec, Misotac400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion | Drug | Misoprostol, Misoprostol/Transcervical catheter |
| Misoprostol/Transcervical catheterAlso: Foley catheterFoleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag | Device | Misoprostol/Transcervical catheter |
Primary outcome
Induction-expulsion interval
Time frame: 48 hours from starting intervention
The duration from the administration of the first misoprostol dose vaginally till complete expulsion of the uterine contents; complete uterine emptiness will be confirmed by ultrasonographic assessment
2 secondary outcomes
Total required doses of misoprostol
Time frame: 48 hours from starting induction
The need for surgical interventions
Time frame: 1 week from starting induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Yes. Data will be available after publication of the study upon formal request by researchers and research centers that collaborate with Ain Shams Maternity Hospital. Data could be obtained through contacting PI by email.
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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.
Alaa Elfeky, Professor principal investigator
AinShams University Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol and Misoprostol/Transcervical catheter in people with Pregnancy Trimester, Second and Misoprostol, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 May 2017. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Elfeky, Professor (+2001222157568, aelfeky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction-expulsion interval (time frame: 48 hours from starting intervention). 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 9 May 2017.