Previable Labour With Intact MembranesPhase 3ECHEC-MATNCT06572761
A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
A Phase 3 study testing Combination of antibiotics, Emergency cerclage and Vaginal progesterone in people with Previable Labour With Intact Membranes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Previable Labour With Intact Membranes
- What is being tested?
- Combination of antibiotics, Emergency cerclage and Vaginal progesterone
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Threatened previable prelabor with intact membranes between 18weeks of gestation +0/7 and 23 weeks of gestation 6/7 SA defined on endovaginal ultrasound by a short cervix ≤10 mm, and/or protrusion of the membranes on speculum examination.
- Maternal age >18 years
- Affiliated with social security
- Correct understanding of the French language
- Singleton pregnancy
- Foetus alive at time of inclusion
- Absence of regular and painful uterine contractions
Who cannot join
- Premature labor defined by regular, painful uterine contractions and a short cervix
- Protected person (patient under guardianship/curatorship/or legal protection)
- Multiple pregnancies
- Premature rupture of membranes
- Acute chorioamnionitis
- Contraindication to protocol antibiotics
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- Chromosomal abnormality, congenital malformation
- Patients who received antibiotics before randomization, or requiring antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)
- Participation in another research (Specify the category: RIPH, EC, IC, etc.) or being in the exclusion period following previous research involving humans, if applicable
- Patient under AME (if no exemption from affiliation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Poissy-Saint Germain
Poissy, 78300
Thibaud QUIBEL, MD, PhD, 0178636012
About this study
Official title: A Combination of Antibiotics to Decrease Neonatal Mortality and Morbidity for Pregnancies Complicated With Previable Labour and Intact Membranes: a Multicenter, Open-label, Randomized and Controlled Trial
The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes.
Read the detailed description
Observational data suggest that subclinical infectious conditions can lead to spontaneous preterm labor. 10% of births are premature, but the morbidity/mortality of premature babies is concentrated mainly among newborns born before 30 weeks of gestation or weighing less than 1500 g. The relationship to infection/inflammation and premature birth is not constant throughout pregnancy, but this infectious risk increases the earlier the gestational age of spontaneous labor is (before 30 weeks). The pathogens that have the strongest associations with premature birth are Gardnerella vaginalis, Ureaplasma urealyticum and Mycoplasma hominis, but also Streptococcus B, Escherichia coli, Klebsiella spp, or Haemophilus influenzae.
Antibiotic treatment to treat an intra-amniotic infection is considered ineffective. Indeed, the last randomized trial (Oracle 2, 2001), which studied several antibiotic regimens for threatened premature delivery with intact membranes, did not find a significant reduction in neonatal morbidity/mortality after administration of co-beta-lactam, erythromycin or the combination of both. In addition, this large trial dominates the results of the latest Cochrane meta-analysis which evaluated preventive antibiotic therapy to stop premature labor with intact membranes.
Recently, it has been showed that a new combination of antibiotics (ceftriaxone, clarithromycin and metronidazole) reduced the risk of infection and intra-amniotic inflammation in preterm labor with intact membranes. This retrospective study deserves to be confirmed by a randomized study
The investigator's goal is to study whether a new combination of antibiotics in a very limited population of pregnancies complicated by the threat of late miscarriage would make it possible to prolong pregnancies in order to improve neonatal outcomes.
- Conditions
- Previable Labour With Intact Membranes
- Being tested
- Combination of antibiotics, Emergency cerclage, Vaginal progesterone
- Keywords
- previable labour, preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of antibioticsDrug
Also called Ceftriaxone; clarithromycin, metronidazole
Ceftriaxone : 1g/day parenteral clarithromycin 500 mg*2/day orally metronidazole 500mg*3/ day orally
Emergency cerclageDevice
Emergency cerclage
Vaginal progesteroneDrug
Vaginal progesterone
| Study group | Role | What they receive |
|---|---|---|
| Combination of antibiotics | Experimental | Combination of antibiotics (3rd generation of cephalosporin, clarithromycin, metronidazole)
+ routine care (emergency cerclage, vaginal progesterone) Receives: Drug: Combination of antibiotics; Device: Emergency cerclage; Drug: Vaginal progesterone |
| Routine care | Active comparator | Routine care (emergency cerclage, vaginal progesterone) Receives: Device: Emergency cerclage; Drug: Vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
A perinatal composite outcome
- Late miscarriage
- Perinatal mortality
- Bronchodysplasia,
- Sepsis proven by blood culture,
- Intraventricular hemorrhage ≥3,
- Periventricular leukomalacia ≥2,
- Ulcero-necrotizing enterocolitis at stage ≥2 according to the Bell classification.
Measured: Up to 24 weeks
Secondary outcomes (3)
Gestationnal age at delivery
- Gestationnal age at delivery ≥ 24 weeks of gestation (wg) 0/7, 28 wg0/7, 32 wg0/7, 34 wg0/7 et 37 wg0/7
- Latency period between randomisation and delivery (≥2 days, ≥7 days, ≥14 days et ≥28 days)
Measured: 6 months
Maternal Morbidty
Chorioamniotitis, postpartum endometritis , sepsis proven par positive hemocultures
Measured: 6 months
Bacteriological
Acquisition of multi-resistant germs during childbirth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study startSep 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previable Labour With Intact MembranesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Thibaud QUIBEL, MD, PhD, Principal investigator, Centre Hospitalier Poissy-Saint GermainJean BOUYER, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572761
- Sponsor's protocol ID
- APHP220670
- Other IDs
- 2023-505500-37-00, 2023
- Acronym
- ECHEC-MAT
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Antibiotics to Decrease Neonatal Mortality and Morbidity for Pregnancies Complicated With Previable Labour and Intact Membranes: a Multicenter, Open-label, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT06572761
- Acronym / sponsor ID
- ECHEC-MAT / APHP220670
- Conditions
- Previable Labour With Intact Membranes
- Keywords
- previable labour, preterm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes.
Detailed description
Observational data suggest that subclinical infectious conditions can lead to spontaneous preterm labor. 10% of births are premature, but the morbidity/mortality of premature babies is concentrated mainly among newborns born before 30 weeks of gestation or weighing less than 1500 g. The relationship to infection/inflammation and premature birth is not constant throughout pregnancy, but this infectious risk increases the earlier the gestational age of spontaneous labor is (before 30 weeks). The pathogens that have the strongest associations with premature birth are Gardnerella vaginalis, Ureaplasma urealyticum and Mycoplasma hominis, but also Streptococcus B, Escherichia coli, Klebsiella spp, or Haemophilus influenzae.
Antibiotic treatment to treat an intra-amniotic infection is considered ineffective. Indeed, the last randomized trial (Oracle 2, 2001), which studied several antibiotic regimens for threatened premature delivery with intact membranes, did not find a significant reduction in neonatal morbidity/mortality after administration of co-beta-lactam, erythromycin or the combination of both. In addition, this large trial dominates the results of the latest Cochrane meta-analysis which evaluated preventive antibiotic therapy to stop premature labor with intact membranes.
Recently, it has been showed that a new combination of antibiotics (ceftriaxone, clarithromycin and metronidazole) reduced the risk of infection and intra-amniotic inflammation in preterm labor with intact membranes. This retrospective study deserves to be confirmed by a randomized study
The investigator's goal is to study whether a new combination of antibiotics in a very limited population of pregnancies complicated by the threat of late miscarriage would make it possible to prolong pregnancies in order to improve neonatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of antibiotics | Experimental | Drug: Combination of antibiotics, Device: Emergency cerclage, Drug: Vaginal progesteroneCombination of antibiotics (3rd generation of cephalosporin, clarithromycin, metronidazole) + routine care (emergency cerclage, vaginal progesterone) |
| Routine care | Active comparator | Device: Emergency cerclage, Drug: Vaginal progesteroneRoutine care (emergency cerclage, vaginal progesterone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Threatened previable prelabor with intact membranes between 18weeks of gestation +0/7 and 23 weeks of gestation 6/7 SA defined on endovaginal ultrasound by a short cervix ≤10 mm, and/or protrusion of the membranes on speculum examination.
- Maternal age >18 years
- Affiliated with social security
- Correct understanding of the French language
- Singleton pregnancy
Key exclusion criteria (10 listed)
- Premature labor defined by regular, painful uterine contractions and a short cervix
- Protected person (patient under guardianship/curatorship/or legal protection)
- Multiple pregnancies
- Premature rupture of membranes
- Acute chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of antibioticsAlso: Ceftriaxone; clarithromycin, metronidazoleCeftriaxone : 1g/day parenteral clarithromycin 500 mg*2/day orally metronidazole 500mg*3/ day orally | Drug | Combination of antibiotics |
| Emergency cerclageEmergency cerclage | Device | Combination of antibiotics, Routine care |
| Vaginal progesteroneVaginal progesterone | Drug | Combination of antibiotics, Routine care |
Primary outcome
A perinatal composite outcome
Time frame: Up to 24 weeks
* Late miscarriage * Perinatal mortality * Bronchodysplasia, * Sepsis proven by blood culture, * Intraventricular hemorrhage ≥3, * Periventricular leukomalacia ≥2, * Ulcero-necrotizing enterocolitis at stage ≥2 according to the Bell classification.
3 secondary outcomes
Gestationnal age at delivery
Time frame: 6 months
Maternal Morbidty
Time frame: 6 months
Bacteriological
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibaud QUIBEL, MD, PhD principal investigator
Centre Hospitalier Poissy-Saint Germain
Jean BOUYER study chair
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination of antibiotics, Emergency cerclage and Vaginal progesterone in people with Previable Labour With Intact Membranes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibaud QUIBEL, MD, PhD (0178636012, thibaud.quibel@ght-yvelinesnord.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A perinatal composite outcome (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.