Clinical trial NCT03194230: Interest of Cervical Dilators in Second Trimester Termination of Pregnancy
Official title: Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Termination of Pregnancy (TOP)
Keywords: Cervical dilators
induction of labor
cervical ripening
medical termination of pregnancy
second-trimester of pregnancy.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-06-21
Enrollment: 355
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women achieving vaginal delivery within 12 hours
timeFrame: 12 hours
Secondary outcomes:
measure: Induction-to-amniotomy interval
timeFrame: 12 hours
measure: Induction-to-delivery interval
timeFrame: 24 hours
measure: Failure in induction of labor
timeFrame: 24 hours
measure: Pain assessment at the beginning of the procedure
timeFrame: Hour 0
measure: Pain assessment of the whole procedure of TOP
timeFrame: 48 hours
measure: Distress assessment at discharge after TOP
timeFrame: 4 months
measure: Assessment of acceptability of the whole procedure of TOP
timeFrame: 4 months
measure: number of complications.
timeFrame: 4 months
measure: Duration of hospitalization.
timeFrame: 48 hours
measure: Cost of the procedure
timeFrame: 4 months
measure: Among nullipara, proportion of women achieving vaginal delivery within 12 hours
timeFrame: 12 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Maternité Port Royal
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Vassilis Tsatsaris, MD, PhD
role: STUDY_DIRECTOR
References:
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(R). Fetal Diagn Ther. 2018;43(1):61-67. doi: 10.1159/000458410. Epub 2017 Mar 29.
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. doi: 10.1016/s0002-9378(96)70270-3.
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.
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. French.
citation: 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.
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. doi: 10.1016/0010-7824(92)90127-f.
citation: 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.