Interest of Cervical Dilators in Second Trimester Termination of Pregnancy (DILATOP)
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|ClinicalTrials.gov Identifier: NCT03194230|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Termination of Pregnancy (TOP)||Other: With cervical dilatator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||325 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.|
|Actual Study Start Date :||December 14, 2017|
|Estimated Primary Completion Date :||August 14, 2020|
|Estimated Study Completion Date :||February 14, 2021|
No Intervention: Without cervical dilator
Induction of labour by oral of 400µg of misoprostol each 3 hours.
Experimental: With cervical dilator
Induction of labour by cervical placement of hygroscopic dilators for 3 hours and oral of 400µg tablets of misoprostol each 3 hours.
Other: With cervical dilatator
Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )
- Proportion of women achieving vaginal delivery within 12 hours [ Time Frame: 12 hours ]The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups.
- Induction-to-amniotomy interval [ Time Frame: 12 hours ]Time between the first placement of misoprostol tablets and artificial amniotomy.
- Induction-to-delivery interval [ Time Frame: 24 hours ]Time between the first placement of misoprostol tablets and delivery.
- Failure in induction of labor [ Time Frame: 24 hours ]Proportion of women not achieving vaginal delivery within 24 hours
- Pain assessment at the beginning of the procedure [ Time Frame: Hour 0 ]Pain assessment with numerical scale at the placement of dilators and the first misoprostol tablets
- Pain assessment of the whole procedure of TOP [ Time Frame: 48 hours ]Pain assessment of the whole procedure by numerical scale at discharge of the hospital
- Distress assessment at discharge after TOP [ Time Frame: 4 months ]Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R)
- Assessment of acceptability of the whole procedure of TOP [ Time Frame: 4 months ]Acceptability measured by the proportion of women who would opt for the same procedure after TOP
- number of complications. [ Time Frame: 4 months ]
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.
- Duration of hospitalization. [ Time Frame: 48 hours ]Duration of hospitalization between admission and discharge and in delivery room.
- Cost of the procedure [ Time Frame: 4 months ]Assessment of the whole procedure costs of TOP, including potential complications.
- Among nullipara, proportion of women achieving vaginal delivery within 12 hours [ Time Frame: 12 hours ]The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194230
|Contact: Olivia Anselem, MD||158 41 37 63 ext +email@example.com|
|Contact: Laurence Lecomte, PhD||1 71 19 64 94 ext +firstname.lastname@example.org|
|Maternité Port Royal||Recruiting|
|Paris, France, 75014|
|Contact: olivia Anselem, MD 1 58 41 37 63 ext +33 email@example.com|
|Contact: Vassilis Tsatsaris, MD, PhD 1 58 41 38 71 ext +33 firstname.lastname@example.org|
|Study Director:||Vassilis Tsatsaris, MD, PhD||Assistance Publique - Hôpitaux de Paris|