Echec-MAT - A combination of antibiotics to improve neonatal mortality and morbidity for pregnancies complicated with previable labour and intact membranes: an open multiple center, randomized, and controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2024-09-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ministry of Health

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Reduce neonatal mortality and severe morbidity by prolonging pregnancies complicated by the threat of late miscarriage with intact membranes

Secondary objectives 5

1. Prolongation of pregnancy
2. Prolongation of the latency period between randomization and delivery
3. Reduction of chorioamnionitis
4. Reduction of postpartum endometritis and maternal sepsis
5. Improvement of neonatal outcomes based on the primary composite judgment criterion:

Conditions and MedDRA coding

Pregnant women with singleton pregnancies hospitalized for threatened late miscarriage with intact membranes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Threat of late miscarriage with intact membranes between 18 0/7 and 23 6/7 weeks of gestation, defined by transvaginal ultrasound as a cervix ≤10 mm, and/or protrusion of the amniotic sac observed with a speculum.
2. Singleton pregnancy
3. Living fetus at the time of inclusion
4. Maternal age >18 years
5. Absence of regular and painful uterine contractions
6. Adequate understanding of the French language
7. Affiliated with social security

Exclusion criteria 10

1. Preterm labor defined by regular and painful uterine contractions, and a short cervix
2. Protected person (patient under guardianship/curatorship/legal protection)
3. Multiple pregnancies
4. Premature rupture of membranes
5. Acute chorioamnionitis
6. Contraindication to the antibiotics in the protocol
7. Chromosomal anomaly, congenital malformation
8. Patients who have received antibiotics before inclusion or who require antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)
9. Participation in another interventional research study or being in the exclusion period following a previous study involving human subjects, if applicable
10. Patient under state medical aid (AME) if not exempted from the affiliation requirement

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage
2. Perinatal mortality
3. Bronchopulmonary dysplasia
4. Sepsis proven by blood culture
5. Intraventricular hemorrhage ≥ Grade 3
6. Periventricular leukomalacia ≥ Grade 2
7. Necrotizing enterocolitis at stage ≥ 2 according to Bell's classification

Secondary endpoints 5

1. Each item of the composite criterion: 1-Neonatal mortality and late miscarriage
2. Bronchopulmonary dysplasia according to international recommendations (described by Jobe and Bancalari), diagnosed at discharge or at a corrected age of 36 6/7 weeks of gestation.
3. Sepsis proven by culture, diagnosed by a combination of clinical signs and a positive blood culture
4. Intraventricular hemorrhage ≥ Grade 3 and/or periventricular leukomalacia, diagnosed by repeated transfontanellar ultrasounds (according to the classification of Vries and Ment)
5. Necrotizing enterocolitis ≥ Stage 2, using Bell's classification.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

coordinating investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

coordinating investigator

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications