Quarenta Semanas: Innovative Intervention in Prenatal Care for Reduction of Prematurity

NCT02506725 | Unknown DMC

• 1 other identifier: OswaldoCruz
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of Quarenta Semanas is to remove risk factors for preterm birth by linking women to prenatal care in the first trimester; supporting, educating and empowering women in pregnancy to reduce maternal stress and interrupt social, psychological, attitudinal and biological risk factors for preterm birth; and providing evidence-based, quality care that identifies and intervenes medically to treat underlying chronic and emergent conditions associated with preterm birth.

Conditions

Pregnancy

Keywords

prenatal care; pregnancy; prematurity

Outcome Measures

Primary Outcomes (1)

• prematurity rate

  birth before 37 weeks of gestational age

  12 months

Secondary Outcomes (2)

• mothers satisfaction

  12 months

• vaginal birth

  12 months

Study Arms (2)

Prenatal Care in groups

EXPERIMENTAL

We will do prenatal care using centering care pregnancy methodology in 10 sessions

Other: prenatal care in groups

Control Group

NO INTERVENTION

We will do in this arm conventional Prenatal care available in the family clinics

Interventions

prenatal care in groups OTHER

We will do prenatal care in groups using centering care pregnancy methodology

Also known as: centering care for prenatal

Prenatal Care in groups

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study:
• women must be at least eighteen years old and pregnant.
• They must be less than 12 weeks pregnant at the time of enrollment.
• They must speak Portuguese.
• Multiple gestation pregnancies will be excluded.

You may not qualify if:

• women who submit reasons not to take part groups after applying the questionnaire

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

Maria Elisabeth Moreira

Rio de Janeiro, Rio de Janeiro, 22250020, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Prenatal Care; Population Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Demography; Population Characteristics

Study Officials

• Shioban Dolan, MD

  Montefiore Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician and qualitative researchers
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PHD

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)