Termination of Pregnancy (TOP) Clinical Trial
— DILATOPOfficial title:
Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.
| Verified date | January 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 355 |
| Est. completion date | November 24, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Termination of pregnancy requested by the patient and accepted by the weekly multidisciplinary counselling of fetal medicine - gestational age between 15 and 27 weeks and 6 days, - single pregnancy, - major patient, - French-speaking woman, - Patient with health insurance. Exclusion Criteria: - Termination of pregnancy by surgical technique - cicatricial uterus - premature rupture of membranes - chorioamnionitis - multiple pregnancy - placenta praevia - myoma praevia - uterine malformation - unstable maternal pathology - psychiatric pathology - contraindication to mifepristone: severe asthma, adrenal insufficiency, porphyria, corticotherapy. - contraindication to misoprostol: hypersensitivity to prostaglandins. - contraindication to epidural analgesia: hemostasis disorder, spinal or medullary anomaly. - Bishop score > or = to 7 at arrival in birth room |
| Country | Name | City | State |
|---|---|---|---|
| France | Maternité Port Royal | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | INSERM U1153 |
France,
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. Review. French. — View Citation
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. — View Citation
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. — View Citation
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. Review. French. — View Citation
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. — View Citation
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®. Fetal Diagn Ther. 2018;43(1):61-67. doi: 10.1159/000458410. Epub 2017 Mar 29. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Induction-to-amniotomy interval | Time between the first placement of misoprostol tablets and artificial amniotomy. | 12 hours | |
| Secondary | Induction-to-delivery interval | Time between the first placement of misoprostol tablets and delivery. | 24 hours | |
| Secondary | Failure in induction of labor | Proportion of women not achieving vaginal delivery within 24 hours | 24 hours | |
| Secondary | 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 | |
| Secondary | Pain assessment of the whole procedure of TOP | Pain assessment of the whole procedure by numerical scale at discharge of the hospital | 48 hours | |
| Secondary | Distress assessment at discharge after TOP | Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R) | 4 months | |
| Secondary | 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 | |
| Secondary | 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).
Cervical injury. Complications of prolonged decubitus: bedsores, thrombo-embolic complications. Uterine rupture. Post-partum hemorrhage defined by estimated blood losses greater than 500 mL. |
4 months | |
| Secondary | Duration of hospitalization. | Duration of hospitalization between admission and discharge and in delivery room. | 48 hours | |
| Secondary | Cost of the procedure | Assessment of the whole procedure costs of TOP, including potential complications. | 4 months | |
| Secondary | 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 |