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Completed

NCT Number: NCT04831086

To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis

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

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Key information

Conditions

Preterm Birth Amniocentesis Affecting Fetus or Newborn Female Urogenital Diseases and Pregnancy Complications Intra-amniotic Infection Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Labor Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fundació Recerca Biomèdica Clínica

Barcelona, 08828, Spain

About this study

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

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Steroid Drug

Drug

Steroids doses will be optimized in the intervention group according the risk based on predictive models

Tocolytic Agents

Drug

Tocolysis duration will be optimized in the intervention group according the risk based on predictive models

Primary outcomes

  1. Antenatal steroid doses

    Time frame: through study completion, an average of 1 year

    Number of antenatal steroid doses administered

Secondary outcomes

  1. maternal stay length

    Time frame: through study completion, an average of 1 year

    Maternal length of hospital stay (in days).

  2. Clinical chorioamnionitis

    Time frame: through study completion, an average of 1 year

    Clinical chorioamnionitis occurrence defined by the presence of maternal fever >=38ºC, fetal tachycardia > 160 bpm, leukocytes > 14000/m2 without steroids effect and cervical purulent fluid

Other outcomes

  1. Tocolysis duration

    Time frame: through study completion, an average of 1 year

    Tocolysis duration (in days)

  2. Gestational age at delivery

    Time frame: through study completion, an average of 1 year

    Gestational age at delivery

  3. Spontaneous delivery within 7 days after admission

    Time frame: through study completion, an average of 1 year

    Spontaneous delivery within 7 days after admission (yes/no),

  4. Microbial invasion of amniotic cavity

    Time frame: through study completion, an average of 1 year

    Microbial invasion of amniotic cavity (yes/no) defined by the presence of a positive amniotic fluid culture, detection of 16S rRNA gene or visualization of microorganisms at the Gram stain

  5. Cost analyses

    Time frame: through study completion, an average of 1 year

    Cost analyses: The following resource items will be collected: maternal and neonatal admissions, method of delivery, type of induction, outpatient visits, emergency visits, medication, surgical procedures, maternal stay length.

  6. Maternal morbidity

    Time frame: through study completion, an average of 1 year

    Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need for transfusion, maternal death.

  7. Neonatal length of hospital stay

    Time frame: through study completion, an average of 1 year

    Neonatal length of hospital stay (days)

  8. Neonatal birthweight (in grams)

    Time frame: through study completion, an average of 1 year

    Neonatal anthropometric measurements

  9. height (in centimeters)

    Time frame: through study completion, an average of 1 year

    Neonatal anthropometric measurements

  10. cephalic, thoracic and abdominal perimeters (in millimeters)

    Time frame: through study completion, an average of 1 year

    Neonatal anthropometric measurements

  11. arm circumference (in centimeters)

    Time frame: through study completion, an average of 1 year

    Neonatal anthropometric measurements

  12. Adverse neonatal outcome

    Time frame: through study completion, an average of 1 year

    A composite adverse neonatal outcome (yes/no) defined as the presence or one or more of the following outcomes: fetal or neonatal death, early onset sepsis, moderate/severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, periventricular leukomalacia, surgical necrotizing enterocolitis, retinopathy requiring laser treatment.

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Collaborators

  • Complexo Hospitalario Universitario de A Coruña
  • Consorci Sanitari de Terrassa
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Germans Trias i Pujol Hospital
  • Hospital Clínico Universitario Lozano Blesa
  • Hospital Sant Joan de Deu
  • Hospital Son Llatzer
  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Fe
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario de Torrejón
  • Hospital Vall d'Hebron
  • Parc Taulí Hospital Universitari
  • University Hospital Virgen de las Nieves

Registry information

Official study 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)

Acronym: OPTIM-PTL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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