Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-01-01
2022-12-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mesotac in mid trimester
Prostaglandin
Misoprostol
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.
Dilapan s in mid trimester
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.
Dilapan s
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.
Interventions
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Dilapan s
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.
Misoprostol
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Reem Nasr Abd el hafez Nasr
Principal investigator
Principal Investigators
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Salma Nassar, MD
Role: STUDY_DIRECTOR
Ainshams maternity hospital
Ayman Abo nour, Prof
Role: PRINCIPAL_INVESTIGATOR
Ainshams maternity hospital
Locations
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Ainshams Maternity Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Salma Nasssar, MD
Role: CONTACT
Phone: +20 100 167 3661
Facility Contacts
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Reem Nasr, Master
Role: primary
References
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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.
Pazol 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.
Johnson 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.
Other Identifiers
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MTD
Identifier Type: -
Identifier Source: org_study_id