Abortion EarlyNCT05147857
Mid Trimester Abortion Effectiveness by Dilapan s
A study testing Dilapan s and Misoprostol in people with Abortion Early, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study is done aiming to find out an effective method to induce second trimester abortion within a reasonable time and with the least possible cost and complications. 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 Early
- What is being tested?
- Dilapan s and Misoprostol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Dec 2022
- 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
- Sure indication of abortion.
- Estimated gestational age between 12-24 weeks as calculated from last normal menstrual period (LNMP) and confirmed by abdominal ultrasound.
- Intact membranes.
- No medical disorder prevents the usage of any of the medications in the study.
Who cannot join
- History of cervical surgery or presence of cervical scarring.
Trial locations and contacts
1 site in 1 country.
Salma Nasssar, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ainshams Maternity Hospital
Cairo, 11856
Reem Nasr, Master, 01012926686, reemnasr92@gmail.com
About this study
Official title: Dilapan Versus Prostaglandin E1 in Induction of Midtrimester Abortion
This study is done aiming to find out an effective method to induce second trimester abortion within a reasonable time and with the least possible cost and complications.
Read the detailed description
od complete history taking and examination will be performed including measurement of blood pressure, pulse and temperature. Skin was examined for petichae or ecchymosis to exclude coagulation defects or blood diseases. The abdominal examination included detection of the size of the uterus (in cm above symphysis pubis), presence of scar of previous laparotomy, tenderness or rigidity. The local examination included detection of uterine size by bimanual examination, cervical dilatation, consistency, effacement, and position.
Each patient was investigated for hemoglobin content, Rh-typing, blood sugar level, Coagulation profile, renal function tests, and liver function tests.
Our patients were divided into 2 groups, each containing-- patients: In the First group, induction of abortion was carried out by prostaglandin E1 methyl analogue, Misoprestol. It was given by vaginal routeIn the second group, induction of abortion will be started with Dilapan.s followed by surgical evacuation In the First group, the initial Bishop score will be recorded and the minimal dose of one tablet was inserted deep in the posterior fornix. The dose will be repeated every 4 hours till the products of conception are expelled. If remnants of conception are retained for more than 30 minutes, oxytocin drip will be initiated starting with a minimal dose of 2.5 U in 500-ml glucose 5%. Failure of induction was considered if uterine contractions and start of expulsion had not occurred within 36 hours from initiation of therapy.
In the second group, The vagina will be prepared with Povidine iodine as an antiseptic, which is also used to moisten the dilators. A sterile speculum will be inserted and after inspection of the cervix, the anterior lip will stabilized with ring forceps. Using gentle traction on the cervix, the Dilapan dilator will be inserted into the cervical canal, the upper vagina will then packed with a sterile gauze to maintain the dilator in place. The dilators were left for a period not less than 6 and not more than 24 hours. After removal of the gauze, the Dilapan handle will be grasped with forceps and removed with gentle steady downward traction on Dialpan loop itself. The cervical dilatation will be measured by Hegar's dilators and recorded. Surgical evacuation will then carried out under general anesthesia. In cases with gestational age more than 16 weeks, an oxytocin infusion will be MasterDegreeThesis/MFA/ISRO/FacultyOfMedicine/ASU Page 4
added to induce uterine contractions and expulsion of the contents. Failure was considered if dilatation of the cervix was not achieved, or if there was no response to oxytocin within 36 hours.
Clinical data were recorded in an investigative report form and Sudent's (t) test was used to compare means, P value of < 0.05 was considered significant.
- Conditions
- Abortion Early
- Being tested
- Dilapan s, Misoprostol
- Keywords
- Abortion, Dilapan s
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilapan sDevice
is an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action.
It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually.
MisoprostolDrug
Also called Misotac
Misoprostol is a synthetic prostaglandin medication used to prevent and treat stomach and duodenal ulcers, induce labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus. Misoprostol is taken by mouth when used to prevent gastric ulcers in persons taking NSAIDs.
| Study group | Role | What they receive |
|---|---|---|
| Mesotac in mid trimester | Active comparator | Prostaglandin Receives: Drug: Misoprostol |
| Dilapan s in mid trimester | Active comparator | is an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action.
It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually. Receives: Device: Dilapan s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abortion
Abortion time in days
Measured: 24 hour from procedure
Secondary outcomes (1)
Hospital stay
Number of days of hospital stay
Measured: 24 hour from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Jan 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Nasr Abd el hafez Nasr, Ain Shams Maternity Hospital
- Investigators
- Salma Nassar, MD, Study director, Ainshams maternity hospitalAyman Abo nour, Prof, Principal investigator, Ainshams maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147857
- Sponsor's protocol ID
- MTD
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones RK, Kooistra K. Abortion incidence and access to services in the United States, 2008. Perspect Sex Reprod Health. 2011 Mar;43(1):41-50. doi: 10.1363/4304111. Epub 2011 Jan 10.
PubMed 21388504Pazol K, Creanga AA, Zane SB, Burley KD, Jamieson DJ; Centers for Disease Control and Prevention (CDC). Abortion surveillance--United States, 2009. MMWR Surveill Summ. 2012 Nov 23;61(8):1-44.
PubMed 23169413Johnson MR, Riddle AF, Grudzinskas JG, Sharma V, Collins WP, Nicolaides KH. Reduced circulating placental protein concentrations during the first trimester are associated with preterm labour and low birth weight. Hum Reprod. 1993 Nov;8(11):1942-7. doi: 10.1093/oxfordjournals.humrep.a137965.
PubMed 7507132
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilapan Versus Prostaglandin E1 in Induction of Midtrimester Abortion
- ClinicalTrials.gov ID
- NCT05147857
- Acronym / sponsor ID
- MTD
- Conditions
- Abortion Early
- Keywords
- Abortion, Dilapan s
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 Dec 2021 (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 study is done aiming to find out an effective method to induce second trimester abortion within a reasonable time and with the least possible cost and complications.
Detailed description
od complete history taking and examination will be performed including measurement of blood pressure, pulse and temperature. Skin was examined for petichae or ecchymosis to exclude coagulation defects or blood diseases. The abdominal examination included detection of the size of the uterus (in cm above symphysis pubis), presence of scar of previous laparotomy, tenderness or rigidity. The local examination included detection of uterine size by bimanual examination, cervical dilatation, consistency, effacement, and position.
Each patient was investigated for hemoglobin content, Rh-typing, blood sugar level, Coagulation profile, renal function tests, and liver function tests.
Our patients were divided into 2 groups, each containing-- patients: In the First group, induction of abortion was carried out by prostaglandin E1 methyl analogue, Misoprestol. It was given by vaginal routeIn the second group, induction of abortion will be started with Dilapan.s followed by surgical evacuation In the First group, the initial Bishop score will be recorded and the minimal dose of one tablet was inserted deep in the posterior fornix. The dose will be repeated every 4 hours till the products of conception are expelled. If remnants of conception are retained for more than 30 minutes, oxytocin drip will be initiated starting with a minimal dose of 2.5 U in 500-ml glucose 5%. Failure of induction was considered if uterine contractions and start of expulsion had not occurred within 36 hours from initiation of therapy.
In the second group, The vagina will be prepared with Povidine iodine as an antiseptic, which is also used to moisten the dilators. A sterile speculum will be inserted and after inspection of the cervix, the anterior lip will stabilized with ring forceps. Using gentle traction on the cervix, the Dilapan dilator will be inserted into the cervical canal, the upper vagina will then packed with a sterile gauze to maintain the dilator in place. The dilators were left for a period not less than 6 and not more than 24 hours. After removal of the gauze, the Dilapan handle will be grasped with forceps and removed with gentle steady downward traction on Dialpan loop itself. The cervical dilatation will be measured by Hegar's dilators and recorded. Surgical evacuation will then carried out under general anesthesia. In cases with gestational age more than 16 weeks, an oxytocin infusion will be MasterDegreeThesis/MFA/ISRO/FacultyOfMedicine/ASU Page 4
added to induce uterine contractions and expulsion of the contents. Failure was considered if dilatation of the cervix was not achieved, or if there was no response to oxytocin within 36 hours.
Clinical data were recorded in an investigative report form and Sudent's (t) test was used to compare means, P value of < 0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesotac in mid trimester | Active comparator | Drug: MisoprostolProstaglandin |
| Dilapan s in mid trimester | Active comparator | Device: Dilapan sis an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sure indication of abortion.
- Estimated gestational age between 12-24 weeks as calculated from last normal menstrual period (LNMP) and confirmed by abdominal ultrasound.
- Intact membranes.
- No medical disorder prevents the usage of any of the medications in the study.
Key exclusion criteria (1 listed)
- History of cervical surgery or presence of cervical scarring.
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 |
|---|---|---|
| Dilapan sis an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually. | Device | Dilapan s in mid trimester |
| MisoprostolAlso: MisotacMisoprostol is a synthetic prostaglandin medication used to prevent and treat stomach and duodenal ulcers, induce labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus. Misoprostol is taken by mouth when used to prevent gastric ulcers in persons taking NSAIDs. | Drug | Mesotac in mid trimester |
Primary outcome
Abortion
Time frame: 24 hour from procedure
Abortion time in days
1 secondary outcome
Hospital stay
Time frame: 24 hour from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Background: PubMed 21388504Jones RK, Kooistra K. Abortion incidence and access to services in the United States, 2008. Perspect Sex Reprod Health. 2011 Mar;43(1):41-50. doi: 10.1363/4304111. Epub 2011 Jan 10.
- Results publication: PubMed 23169413Pazol K, Creanga AA, Zane SB, Burley KD, Jamieson DJ; Centers for Disease Control and Prevention (CDC). Abortion surveillance--United States, 2009. MMWR Surveill Summ. 2012 Nov 23;61(8):1-44.
- Results publication: PubMed 7507132Johnson MR, Riddle AF, Grudzinskas JG, Sharma V, Collins WP, Nicolaides KH. Reduced circulating placental protein concentrations during the first trimester are associated with preterm labour and low birth weight. Hum Reprod. 1993 Nov;8(11):1942-7. doi: 10.1093/oxfordjournals.humrep.a137965.
- Individual participant dataSharing planned: No
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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.
Salma Nasssar, MD contact
Salma Nassar, MD study director
Ainshams maternity hospital
Ayman Abo nour, Prof principal investigator
Ainshams maternity 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 Dilapan s and Misoprostol in people with Abortion Early, 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 4 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 7 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Nasr, Master (01012926686, reemnasr92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abortion (time frame: 24 hour from 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 NCT05147857, which also lists 3 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 Dec 2021.