NCT03659045: DoMy

Pain Assessment in MToP Up to 7 WA (during 5h After Misoprostol Intake)

Completed NA Last updated 23 October 2024

What this trial tests

NA trial testing scale of pain in Abortion-Related Disorders in 320 participants. Completed in 4 April 2023.

Timeline

15 January 2019

Primary endpoint
22 March 2023

4 April 2023

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	320
Start date	15 January 2019
Primary completion	22 March 2023
Estimated completion	4 April 2023
Sites	8 locations across France

Drugs / interventions tested

• scale of pain

Conditions studied

• Abortion-Related Disorders — all drugs for Abortion-Related Disorders →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 18 to 60, female only, with Abortion-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In 2016, medical termination of pregnancy represent 64% of total abortions in France. Thus, it is a frequent act involving a large majority of women and a health-care public subject. The two medicines used in medical abortion are mifepristone and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater than 90% up to 7 SA. Medical abortion may be performed in outpatient basis or in short-terme hospitalization. One of the limits of this technique development is the pain caused by the drugs intake mainly due to the uterine contractions induced by misoprostol intake. Thus it is recommended a systematic analgesics intake but despite these guidelines, pain level reported by the patients remains significant. There is very limited data on the misoprostol influence or mifepristone dose on pain. In a recent observational multicenter study, mifepristone 600 mg was reported to be associated with decreased pain compared with mifepristone 200 mg.

In this context, it is important to confirm by a higher level evidence of study that the protocol using mifepristone 600 mg decreases the pain level of medical abortion compared to a protocol using mifepristone 200 mg. In the absence of benefit, we will not be able to conclude to a benefit on the prevention of pain with a protocol associating 600 mg of mifepristone and 400 μg of misoprostol. If the benefit on pain is confirmed, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of quality of care or medical and economic impact.

The clinical study is interventional, prospective, comparative, randomized, double-blind, multi-center, conducted in 11 French hospitals carrying out voluntary medical termination of pregnancy.

The data will be collected by the physician during the 4 consultations (initial consultation of abortion request, inclusion consultation with Mifegyne® intake, consultation of misoprostol intake (short-terme hospitalization), follow-up consultation from the available data in the patient's medical file and from the questionning and clinical examination data made during these 4 consultations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.