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| Name | Class |
|---|---|
| Ain Shams Maternity Hospital | OTHER |
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The goal of this clinical trial is to compare the induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus. The main question it aims to answer is:
• Is the usage of laminaria japonicum as a mechanical dilator for the cervix followed by Prostaglandin E1 more effective and time saving than using prostaglandin E1 alone in induction of mid-trimester abortion in a previously scarred uterus? Researchers will compare induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus.
Participants in Group A: induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
Participants in Group B: induction of abortion will be carried out by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laminaria japonicum to be followed by Misoprostol | Active Comparator | Induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation. |
|
| Misoprostol only | Active Comparator | Induction of abortion will be carried out only by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol ( Cytotec) 200 microgram a tablet | Drug | 30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation. |
| Measure | Description | Time Frame |
|---|---|---|
| Induction-to-abortion interval time. | Time taken from the start of induction of abortion till occurrence of abortion | From enrollment to the end of abortion, an average of one week |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Operative intervention | Operative intervention needed as suction & evacuation or the need for hystrotomy | From enrollment to the end of abortion, an average of one week |
| Amount of vaginal bleeding |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women who will be admitted to Ain Shams University Maternity Hospital for induction of mid-trimester abortion.
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| Name | Affiliation | Role |
|---|---|---|
| Amr Fathy Ahmed, Professor | Ain Shams Maternity Hospital | Study Chair |
| Mohamed ElMandouh Mohamed, Professor | Ain Shams Maternity Hospital | Study Chair |
| Haitham Mohamed Sabaa, Professor | Ain Shams Maternity Hospital | Study Chair |
| Hamdy Bakry Alqenawy, Lecturer | Ain Shams Maternity Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25646929 | Background | Sagiv R, Mizrachi Y, Glickman H, Kerner R, Keidar R, Bar J, Golan A. Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial. Contraception. 2015 May;91(5):406-11. doi: 10.1016/j.contraception.2015.01.018. Epub 2015 Jan 31. | |
| 8607329 | Background |
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Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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Two arm randomized comparative study.
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| Laminaria Tent | Drug | Laminaria Tent will be used for induction of abortion |
|
The amount of vaginal bleeding with be assessed visually and categorized into mild, moderate & severe.
| From enrollment to the end of abortion, an average of one week |
| Rate of occurrence of uterine rupture followed by hysterectomy | As a complication of the usage of Misoprostol in previous scarred uterus is uterine rupture | From enrollment to the end of abortion, an average of one week |
| The amount of Misoprostol doses needed (microgram) | The doses of Misoprostol needed till expulsion of the fetus in each arm will be compared | Group A: after removal of Laminaria till expulsion of the fetus, an average of one week while for Group B: From enrollment to the end of abortion, an average of one week |
| El Maradny E, Kanayama N, Halim A, Maehara K, Kobayashi T, Terao T. Biochemical changes in the cervical mucus after application of laminaria tent. Acta Obstet Gynecol Scand. 1996 Mar;75(3):203-7. doi: 10.3109/00016349609047087. |
| 31281014 | Background | Lerma K, Blumenthal PD. Current and potential methods for second trimester abortion. Best Pract Res Clin Obstet Gynaecol. 2020 Feb;63:24-36. doi: 10.1016/j.bpobgyn.2019.05.006. Epub 2019 May 25. |
| Background | Joob B and Wiwanitkti V (2016): Laminaria species and usefulness in obstetrics and gynaecology. Journal of Coastal Life Medicine, 2016; 4(3):244-5. |
| 24331860 | Background | Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11. |
| 24461423 | Background | Clouqueur E, Coulon C, Vaast P, Chauvet A, Deruelle P, Subtil D, Houfflin-Debarge V. [Use of misoprostol for induction of labor in case of fetal death or termination of pregnancy during second or third trimester of pregnancy: Efficiency, dosage, route of administration, side effects, use in case of uterine scar]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):146-61. doi: 10.1016/j.jgyn.2013.11.008. Epub 2014 Jan 22. French. |
| 30032065 | Background | Chodankar R, Gupta J, Gdovinova D, Bovo MJ, Hanacek J, Kan N, Roizin J, Tyutyunnik V. Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:249-254. doi: 10.1016/j.ejogrb.2018.07.013. Epub 2018 Jul 11. |
| 26067264 | Background | Cetin C, Buyukkurt S, Seydaoglu G, Kahveci B, Soysal C, Ozgunen FT. Comparison of two misoprostol regimens for mid-trimester pregnancy terminations after FIGO's misoprostol dosage recommendation in 2012. J Matern Fetal Neonatal Med. 2016;29(8):1314-7. doi: 10.3109/14767058.2015.1046831. Epub 2015 Jun 11. |
| 31771801 | Background | Bertholdt C, David MG, Gabriel P, Morel O, Perdriolle-Galet E. Effect of the addition of osmotic dilators to medical induction of labor abortion: A before-and-after study. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:185-189. doi: 10.1016/j.ejogrb.2019.10.013. Epub 2019 Oct 21. |
| 31570024 | Background | Barinov SV, Tirskaya YI, Shamina IV, Medyannikova IV, Kadcyna TV, Shkabarnya LL, Lazareva OV. The use of an osmotic dilator for induction of miscarriage in patients with the second trimester missed miscarriage. J Matern Fetal Neonatal Med. 2021 Sep;34(17):2778-2782. doi: 10.1080/14767058.2019.1671331. Epub 2019 Oct 1. |
| 34030560 | Background | Achenbach AE, Singh S, Jackson B, Caveglia SJ, Berghella V, Seligman NS. Cervical ripening with laminaria tents prior to second trimester induction of labor. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5807-5812. doi: 10.1080/14767058.2021.1893297. Epub 2021 May 24. |
| Background | Abdallah M, Moheb A, Mousa AB, Saleh AM (2022): Comparison between Mechanical induced Cervical Dilatation in Previous Scar Woman in 2nd Trimester Abortion: Non-Randomized Controlled Study. Minia Journal of Medical Research, 2022; 33(1):44-9. |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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