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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate whether the use of cervical dilators for cervical ripening in case of second trimester medical termination of pregnancy (TOP) is effective to reduce duration of labor.
Termination of pregnancy is a distressing and painful procedure for women. The use of cervical dilators could shorten the duration of labor but can generate more pain. The investigators will compare two procedures of induction of labor for second trimester termination of pregnancy: one with the use of oral prostaglandins (misoprostol) only and one with the exact same procedure preceded by cervical ripening with hygroscopic cervical dilators. Epidural analgesia will be effective previously to the placement of cervical dilators and the first tablet of misoprostol. Efficacy will be determined based on the proportion of women achieving vaginal delivery within 12 hours. The beginning of labor will be defined as the first administration of misoprostol tablets in both groups.
The investigators will also evaluate safety by collecting hemorrhage endometritis, cervical tear. The investigators will compare psychological impact of these procedures, measured by the impact of event scale and acceptability 1 to 4 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without cervical dilator | No Intervention | Induction of labour by oral of 400µg of misoprostol each 3 hours. | |
| With cervical dilator | Experimental | Induction of labour by cervical placement of hygroscopic dilators for 3 hours and oral of 400µg tablets of misoprostol each 3 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With cervical dilatator | Other | Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women achieving vaginal delivery within 12 hours | The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Induction-to-amniotomy interval | Time between the first placement of misoprostol tablets and artificial amniotomy. | 12 hours |
| Induction-to-delivery interval | Time between the first placement of misoprostol tablets and delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vassilis Tsatsaris, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternité Port Royal | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28351055 | Background | Vincienne M, Anselem O, Cordier AG, Le Ray C, Tsatsaris V, Benachi A, Goffinet F. Comparison of the Induction-to-Delivery Interval in Terminations of Pregnancy with or without Dilapan-S(R). Fetal Diagn Ther. 2018;43(1):61-67. doi: 10.1159/000458410. Epub 2017 Mar 29. | |
| 8694046 | Background | Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7. doi: 10.1016/s0002-9378(96)70270-3. |
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| 24 hours |
| Failure in induction of labor | Proportion of women not achieving vaginal delivery within 24 hours | 24 hours |
| Pain assessment at the beginning of the procedure | Pain assessment with numerical scale at the placement of dilators and the first misoprostol tablets | Hour 0 |
| Pain assessment of the whole procedure of TOP | Pain assessment of the whole procedure by numerical scale at discharge of the hospital | 48 hours |
| Distress assessment at discharge after TOP | Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R) | 4 months |
| Assessment of acceptability of the whole procedure of TOP | Acceptability measured by the proportion of women who would opt for the same procedure after TOP | 4 months |
| number of complications. | Hyperthermia> 40 ° C, septicemia, endometritis defined by a fever associated with pelvic pain, positive bacteriological vaginal specimen and a biological infectious syndrome (leukocytosis greater than 15 000 / mm3 and C-Reactive Protein > 10 IU / mL).
| 4 months |
| Duration of hospitalization. | Duration of hospitalization between admission and discharge and in delivery room. | 48 hours |
| Cost of the procedure | Assessment of the whole procedure costs of TOP, including potential complications. | 4 months |
| Among nullipara, proportion of women achieving vaginal delivery within 12 hours | The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups. | 12 hours |
| 19501224 | Background | Mazouni C, Vejux N, Menard JP, Bruno A, Boubli L, d'Ercole C, Bretelle F. Cervical preparation with laminaria tents improves induction-to-delivery interval in second- and third-trimester medical termination of pregnancy. Contraception. 2009 Jul;80(1):101-4. doi: 10.1016/j.contraception.2009.01.013. Epub 2009 Mar 4. |
| 24440001 | Background | Pluchon M, Winer N. [Misoprostol in case of termination of pregnancy in the second and third trimesters. Trials]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):162-8. doi: 10.1016/j.jgyn.2013.11.009. Epub 2014 Jan 16. French. |
| 21185133 | Background | Gitz L, Morel O, Thiebaugeorges O, Sibiude J, Desfeux P, Barranger E. [Termination of pregnancy and intra-uterine fetal death after 14 weeks of pregnancy: Which protocol for induction of labour in 2010?]. J Gynecol Obstet Biol Reprod (Paris). 2011 Feb;40(1):1-9. doi: 10.1016/j.jgyn.2010.11.007. Epub 2010 Dec 23. French. |
| 1424619 | Background | Thong KJ, Baird DT. A study of gemeprost alone, dilapan or mifepristone in combination with gemeprost for the termination of second trimester pregnancy. Contraception. 1992 Jul;46(1):11-7. doi: 10.1016/0010-7824(92)90127-f. |
| 35926202 | Result | Anselem O, Jouannic JM, Winer N, Bouchghoul H, Vivanti AJ, Quibel T, Massardier J, Rousseau J, Ancel PY, Goffinet F, Tsatsaris V. Cervical Dilators Used Concurrently With Misoprostol to Shorten Labor in Second-Trimester Termination of Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2022 Sep 1;140(3):453-460. doi: 10.1097/AOG.0000000000004887. Epub 2022 Aug 3. |