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

Preterm Birth Clinical Trial

— OPTIM-PTL  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831086
• Other study ID #: OPTIM-PTL
• Status: Recruiting
• Phase: Phase 3
• Start date: May 5, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2022
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Teresa Cobo, MD,PhD
• Phone: +34 93 227 54 00
• Email: tcobo[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Amniocentesis Affecting Fetus or Newborn
• Intra-amniotic Infection
• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth
• Preterm Labor

Intervention

Drug:
• Steroid Drug
Steroids doses will be optimized in the intervention group according the risk based on predictive models
• Tocolytic Agents
Tocolysis duration will be optimized in the intervention group according the risk based on predictive models

Locations

Country	Name	City	State
Spain	Fundació Recerca Biomèdica Clínica	Barcelona

Sponsors (13)

Lead Sponsor

Collaborator

Fundacion Clinic per a la Recerca Biomédica

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 Parc Taulí, Sabadell, Hospital Sant Joan de Deu, Hospital Universitario 12 de Octubre, Hospital Universitario La Fe, Hospital Universitario La Paz, Hospital Universitario Puerta del Mar, Hospital Vall d'Hebron, University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martínez-Portilla RJ, Gratacós E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tocolysis duration	Tocolysis duration (in days)	through study completion, an average of 1 year
Other	Gestational age at delivery	Gestational age at delivery	through study completion, an average of 1 year
Other	Spontaneous delivery within 7 days after admission	Spontaneous delivery within 7 days after admission (yes/no),	through study completion, an average of 1 year
Other	Microbial invasion of amniotic cavity	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	through study completion, an average of 1 year
Other	Cost analyses	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.	through study completion, an average of 1 year
Other	Maternal morbidity	Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need for transfusion, maternal death.	through study completion, an average of 1 year
Other	Neonatal length of hospital stay	Neonatal length of hospital stay (days)	through study completion, an average of 1 year
Other	Neonatal birthweight (in grams)	Neonatal anthropometric measurements	through study completion, an average of 1 year
Other	height (in centimeters)	Neonatal anthropometric measurements	through study completion, an average of 1 year
Other	cephalic, thoracic and abdominal perimeters (in millimeters)	Neonatal anthropometric measurements	through study completion, an average of 1 year
Other	arm circumference (in centimeters)	Neonatal anthropometric measurements	through study completion, an average of 1 year
Other	Adverse neonatal outcome	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.	through study completion, an average of 1 year
Primary	Antenatal steroid doses	Number of antenatal steroid doses administered	through study completion, an average of 1 year
Secondary	maternal stay length	Maternal length of hospital stay (in days).	through study completion, an average of 1 year
Secondary	Clinical chorioamnionitis	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	through study completion, an average of 1 year

External Links

•   Predictive models of spontaneous delivery within 7 days and of intra-amniotic infections description