Cervical Preparation of Abortions Under Paracervical Block in the First Trimester:

NCT03043014 | Completed

• 1 other identifier: 2016-35
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world. 90% of the abortions are performed during the first trimester of pregnancy before 13 weeks. Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %.

Conditions

Surgical Abortion

Outcome Measures

Primary Outcomes (2)

• per operative pain

  It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).

  20 minutes

• Anxiety

  STAI anxiety questionnaire;it is a self-questionnaire, developed by Spielberger (Spielberger, 1983) and validated in French (Gauthier \& Bouchard, 1993). It consists of 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence of anxiety.

  48 hours

Study Arms (2)

Mifépristone group

EXPERIMENTAL

Drug: Mifépristone versus Misoprostol

misoprostol group

ACTIVE COMPARATOR

Drug: Mifépristone versus Misoprostol

Interventions

Mifépristone versus Misoprostol DRUG

The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.

Mifépristone group; misoprostol group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 or over with a single intra uterine pregnancy whose term is between 6 and 14 weeks the day of the abortion estimated by ultrasound by a measurement of the cranio-caudal length between 5 and 84 millimeters surgical abortion under local anesthesia informed written consent

You may not qualify if:

• minor multiple pregnancy Uterine malformation coagulation disorder defined by biological parameters (TP\<70%, TCA patient / control ratio \< 1.20) Allergy or hypersensitivity to any of the active substance or to any of the excipients Contraindication to mifepristone chronic renal insufficiency severe asthma uncontrolled by treatment hereditary porphyria allergy to the active substance or to any of the excipients; not affiliated to the social security system; no informed consent. Suspicion of ectopic pregnancy

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de la conception Assistance Publique Hôpitaux de Marseille

Marseille, France

Location

Related Publications (1)

• Hamdaoui N, Cardinale C, Fabre C, Baumstarck K, Agostini A. Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):1055-1060. doi: 10.1097/AOG.0000000000004376.

  PMID: 33957651 DERIVED

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . We assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 3, 2017
• Study Start: June 1, 2017
• Primary Completion: March 13, 2019
• Study Completion: November 15, 2022
• Last Updated: November 16, 2022

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)