Termination of Pregnancy (TOP)
Conditions
Keywords
Cervical dilators, induction of labor, cervical ripening, medical termination of pregnancy, second-trimester of pregnancy.
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.
Interventions
OTHERWith cervical dilatator
Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women achieving vaginal delivery within 12 hours | 12 hours | The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Induction-to-delivery interval | 24 hours | Time between the first placement of misoprostol tablets and delivery. |
| Failure in induction of labor | 24 hours | Proportion of women not achieving vaginal delivery within 24 hours |
| Pain assessment at the beginning of the procedure | 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 | 48 hours | Pain assessment of the whole procedure by numerical scale at discharge of the hospital |
| Distress assessment at discharge after TOP | 4 months | Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R) |
| Induction-to-amniotomy interval | 12 hours | Time between the first placement of misoprostol tablets and artificial amniotomy. |
| number of complications. | 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. | 48 hours | Duration of hospitalization between admission and discharge and in delivery room. |
| Cost of the procedure | 4 months | Assessment of the whole procedure costs of TOP, including potential complications. |
| Among nullipara, proportion of women achieving vaginal delivery within 12 hours | 12 hours | The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups. |
| Assessment of acceptability of the whole procedure of TOP | 4 months | Acceptability measured by the proportion of women who would opt for the same procedure after TOP |
Countries
France
Outcome results
None listed