Clinical trial NCT04831086: To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis
Official title: To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Preterm Labor
Intra-amniotic Infection
Amniocentesis Affecting Fetus or Newborn
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Hospital Universitario La Fe
name: Hospital Universitario La Paz
name: Hospital Universitario 12 de Octubre
name: Consorci Sanitari de Terrassa
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Universitario Puerta del Mar
name: Hospital Sant Joan de Deu
name: Germans Trias i Pujol Hospital
name: University Hospital Virgen de las Nieves
name: Hospital Clínico Universitario Lozano Blesa
name: Parc Taulí Hospital Universitari
name: Complexo Hospitalario Universitario de A Coruña
name: Hospital Son Llatzer
name: Hospital Universitari Joan XXIII de Tarragona.
name: Hospital Universitario de Torrejón
First posted: 2021-04-05
Enrollment: 247
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor and intact membranes between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
Primary purpose: TREATMENT

Brief summary: Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes

Detailed description: To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:

1. Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes.
2. It is a cost-effective strategy.
3. It improves neonatal outcome (in premature newborns \<30 weeks), and reduces infectious maternal morbility.
4. It improves neurodevelopmental outcome at 1.2 and 5 years.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.

Exclusion Criteria:

* Women who do no accept to be part of the study
* Maternal age \< 18 years
* Multiple gestations
* Clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºC), fetal tachycardia (\>160 heart beat per minute \>10 minutes), maternal White blood cells \> 15000/mm3 (not justified by the administration of antenatal steroids).
* Cervical dilatation \> 3 cm
* Major structural malformations of fetal complications that are related to neurodevelopmental impairment.
* Technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration).

Primary outcomes:
measure: Antenatal steroid doses
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: maternal stay length
timeFrame: through study completion, an average of 1 year
measure: Clinical chorioamnionitis
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Tocolysis duration
timeFrame: through study completion, an average of 1 year
measure: Gestational age at delivery
timeFrame: through study completion, an average of 1 year
measure: Spontaneous delivery within 7 days after admission
timeFrame: through study completion, an average of 1 year
measure: Microbial invasion of amniotic cavity
timeFrame: through study completion, an average of 1 year
measure: Cost analyses
timeFrame: through study completion, an average of 1 year
measure: Maternal morbidity
timeFrame: through study completion, an average of 1 year
measure: Neonatal length of hospital stay
timeFrame: through study completion, an average of 1 year
measure: Neonatal birthweight (in grams)
timeFrame: through study completion, an average of 1 year
measure: height (in centimeters)
timeFrame: through study completion, an average of 1 year
measure: cephalic, thoracic and abdominal perimeters (in millimeters)
timeFrame: through study completion, an average of 1 year
measure: arm circumference (in centimeters)
timeFrame: through study completion, an average of 1 year
measure: Adverse neonatal outcome
timeFrame: through study completion, an average of 1 year
Locations:
city: Barcelona
country: Spain
facility: Fundació Recerca Biomèdica Clínica
Study officials:
affiliation: Fundació Recerca Biomèdica Clínica
name: Teresa Cobo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martinez-Portilla RJ, Gratacos E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity in women with preterm labor. Am J Obstet Gynecol. 2020 Sep;223(3):421.e1-421.e14. doi: 10.1016/j.ajog.2020.02.049. Epub 2020 Mar 5.
citation: Cobo T, Aldecoa V, Bartha JL, Bugatto F, Paz Carrillo-Badillo M, Comas C, Diago-Almeda V, Ferrero S, Goya M, Herraiz I, Marti-Malgosa L, Olivella A, Paules C, Vives A, Figueras F, Palacio M, Gratacos E; OPTIM-PTL group. Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study). BMJ Open. 2021 Sep 28;11(9):e054711. doi: 10.1136/bmjopen-2021-054711.