Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)

The University of Texas Health Science Center, Houston1 site in 1 country100 target enrollmentMarch 10, 2020

ConditionsPreterm Premature Rupture of the Membranes Pregnancy Complications Pregnancy, High Risk

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preterm Premature Rupture of the Membranes
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 100
Locations: 1
Primary Endpoint: Latency (measured in days) from from randomization to delivery
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Ambulation in pregnancy has been proposed to decrease stress and anxiety, increasing preterm birth. Whether ambulation is causally related to latency is unknown. The FitBit will be used for tracking the number of steps taken daily by each participant, and for encouraging the intervention group to walk. The FitBit is the most widely used physical activity tracker in medical research, and its use has been validated for research use in pregnant women. The purpose of the study is to evaluate whether ambulation in patients with preterm premature rupture of the membranes (PPROM) prolongs latency.

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

March 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Beth Leong Pineles

Fellow

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Latency (measured in days) from from randomization to delivery

Time Frame: 12 weeks

Secondary Outcomes

Maternal Infectious morbidity(at delivery)
# of subjects with Cesarean delivery (and emergent cesarean delivery)(at delivery)
Time to delivery (time-to-event outcome)(12 weeks)
Fetal or neonatal death(at discharge)
Composite adverse fetal/neonatal outcome(at discharge)
Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)(7 days)
Umbilical arterial pH < 7.00(at delivery)
# of neonates with Small for gestational age(at delivery)
Gestational age at delivery < 34 weeks(at delivery)
Neonatal length of hospital stay, based on admission to NICU or intermediate care unit(at discharge)
# of subjects with Placental abruption(at delivery)
# of subjects with Maternal venous thromboembolism(at delivery)
Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)(7 days)
# of neonates with Neonatal necrotizing enterocolitis (NEC)(at discharge)
# of neonates with Bronchopulmonary dysplasia (BPD)(at discharge)
Composite adverse maternal outcome (CMAO)(at discharge)
Maternal Readmission(within 6 weeks of delivery- 6 weeks)
Delivered at >7 days post randomization(at delivery)
Maternal antepartum hospitalization length of stay(from admission to delivery)
Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)(7 days)
Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups(at delivery)
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV(at discharge)
# of neonates with Neonatal periventricular leukomalacia (PVL)(at discharge)
# of neonates with Neonatal retinopathy of prematurity (ROP).(at discharge)
# of subjects with Umbilical cord prolapse(at delivery)
Apgar score < 5 at 5 minutes of life(at delivery)
Gestational age at delivery < 28 weeks(at delivery)