Induction of AbortionNCT02842164
Foley's Catheter Balloon for Induction of Mid Trimester Abortion in Nulliparous Women With or Without Tension Applied
A study testing Tension group, No tension group and Foley catheter Balloon in people with Induction of Abortion, run by Assiut University at 1 site in Egypt.
Trial summary
Induction of abortion is a hot subject that has complex and emotional controversy. The most common time of abortion is the second trimester which represent about 10-15% of all induced abortions over the world. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Induction of Abortion
- What is being tested?
- Tension group, No tension group and Foley catheter Balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Sep 2017
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton second trimester (12-28 weeks) pregnancy.
- Nulliparous woman.
- Bishop score ≤ 6.
- BMI 18-22.5 kg/m2
Who cannot join
- Multiple gestations.
- Premature rupture of membranes before induction.
- Pregnancy complicated by antepartum hemorrhage (placenta previa or abruptio placenta).
- Low amniotic fluid volume (< 5cm).
- Scarred uterus including hysterotomy or myomectomy.
- Uterine infection.
- Unexplained bleeding.
- Latex allergy
Trial locations and contacts
1 site in 1 country.
About this study
Induction of abortion is a hot subject that has complex and emotional controversy. The most common time of abortion is the second trimester which represent about 10-15% of all induced abortions over the world. As well as, two-thirds of all serious abortion-related complications are related to induced second trimester abortion.
There are many causes for induction of abortion in the second trimester such as missed abortion, serious fetal abnormalities such as central nervous system or skeletal malformation and lastly some women do not wish to continue a pregnancy and will often seek out termination of pregnancy.
Read more
Termination of second trimester is more risky than the first trimester. So many lines have been emerged to achieve safe and effective method of termination of second trimester.
Pharmacologic management seems to be an appealing method for induction of abortion. The combing between mifepristone and misoprostol is the effective regimen for termination of second trimester abortion with success rate reaching about 97-99% within 24 hours.
However, mifepristone is not available or affordable in many countries worldwide so misoprostol have been used alone but it needs higher total dose with lower effectiveness and higher percentage of side effects rate than the combined regimens.
The optimal method for inducing second trimester nulliparous women with an unfavorable cervix is not known. Several studies in literature have described the effectiveness of Foley's catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices . It may act in addition to its mechanical effect by increasing the release of prostaglandin and/or oxytocin release secondary to localized inflammation.
In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying tension in trial to shorten the time between the insertion and expulsion of the fetus, however; this tension adds more pain for the pregnant women with higher rate of vaginal bleeding and dissatisfaction.
Gary et al in 2016 concluded that the application of tension did not result in faster delivery times, but did result in faster times to catheter expulsion.
- Conditions
- Induction of Abortion
- Being tested
- Tension group, No tension group, Foley catheter Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension groupOther
No tension groupOther
Foley catheter BalloonOther
| Study group | Role | What they receive |
|---|---|---|
| Foley Catheter Balloon with Tension group | Other | a 16 French transcervical Foley catheter balloon will be advanced to or past the internal os and the balloon will be filled. Then catheter will be placed on gentle traction by taping the distal tip to the medial thigh for maximum 24 hours. To maintain gentle traction, periodic repositioning of the distal tip on the thigh will be necessary. Receives: Other: Tension group; Other: Foley catheter Balloon |
| Foley Catheter Balloon without tension group | Other | The Foley catheter balloon will be just supported by simple taping to the thigh. Receives: Other: No tension group; Other: Foley catheter Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain provoked by catheter measured by visual analogue scale
Measured: 6 hours
Secondary outcomes (1)
The time from insertion of Foley catheter balloon to catheter expulsion.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of AbortionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842164
- Sponsor's protocol ID
- FIOA
- Status last verified
- Feb 2018
- First submitted
- 15 Jul 2016
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley's Catheter Balloon for Induction of Mid Trimester Abortion in Nulliparous Women With or Without Tension Applied
- ClinicalTrials.gov ID
- NCT02842164
- Acronym / sponsor ID
- FIOA
- Conditions
- Induction of Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Jul 2016 (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 of abortion is a hot subject that has complex and emotional controversy. The most common time of abortion is the second trimester which represent about 10-15% of all induced abortions over the world. As well as, two-thirds of all serious abortion-related complications are related to induced second trimester abortion.
There are many causes for induction of abortion in the second trimester such as missed abortion, serious fetal abnormalities such as central nervous system or skeletal malformation and lastly some women do not wish to continue a pregnancy and will often seek out termination of pregnancy.
Termination of second trimester is more risky than the first trimester. So many lines have been emerged to achieve safe and effective method of termination of second trimester.
Pharmacologic management seems to be an appealing method for induction of abortion. The combing between mifepristone and misoprostol is the effective regimen for termination of second trimester abortion with success rate reaching about 97-99% within 24 hours.
However, mifepristone is not available or affordable in many countries worldwide so misoprostol have been used alone but it needs higher total dose with lower effectiveness and higher percentage of side effects rate than the combined regimens.
The optimal method for inducing second trimester nulliparous women with an unfavorable cervix is not known. Several studies in literature have described the effectiveness of Foley's catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices . It may act in addition to its mechanical effect by increasing the release of prostaglandin and/or oxytocin release secondary to localized inflammation.
In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying tension in trial to shorten the time between the insertion and expulsion of the fetus, however; this tension adds more pain for the pregnant women with higher rate of vaginal bleeding and dissatisfaction.
Gary et al in 2016 concluded that the application of tension did not result in faster delivery times, but did result in faster times to catheter expulsion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley Catheter Balloon with Tension group | Other | Other: Tension group, Other: Foley catheter Balloona 16 French transcervical Foley catheter balloon will be advanced to or past the internal os and the balloon will be filled. Then catheter will be placed on gentle traction by taping the distal tip to the medial thigh for maximum 24 hours. To maintain gentle traction, periodic repositioning of the distal tip on the thigh will be necessary. |
| Foley Catheter Balloon without tension group | Other | Other: No tension group, Other: Foley catheter BalloonThe Foley catheter balloon will be just supported by simple taping to the thigh. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton second trimester (12-28 weeks) pregnancy.
- Nulliparous woman.
- Bishop score ≤ 6.
- BMI 18-22.5 kg/m2
Key exclusion criteria (8 listed)
- Multiple gestations.
- Premature rupture of membranes before induction.
- Pregnancy complicated by antepartum hemorrhage (placenta previa or abruptio placenta).
- Low amniotic fluid volume (< 5cm).
- Scarred uterus including hysterotomy or myomectomy.
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 |
|---|---|---|
| Tension group | Other | Foley Catheter Balloon with Tension group |
| No tension group | Other | Foley Catheter Balloon without tension group |
| Foley catheter Balloon | Other | Foley Catheter Balloon with Tension group, Foley Catheter Balloon without tension group |
Primary outcome
The degree of pain provoked by catheter measured by visual analogue scale
Time frame: 6 hours
1 secondary outcome
The time from insertion of Foley catheter balloon to catheter expulsion.
Time frame: 12 hours
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 2 Mar 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension group, No tension group and Foley catheter Balloon in people with Induction of Abortion, run by Assiut University 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 4 inclusion and 8 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 2 Mar 2018. 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.
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?
The degree of pain provoked by catheter measured by visual analogue scale (time frame: 6 hours). 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 2 Mar 2018.