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Preterm Premature Rupture of the Memb...
+2

Ambulation for Latency During Expectant Management of PPROM

Sponsored by The University of Texas Health Science Center, Houston

About this trial

Last updated 2 years ago

Study ID

HSC-MS-19-0982

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
12 to 55 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Pregnant women aged 12-55

- Gestational age 23 0/7 to 35 0/7 weeks

- PPROM confirmed by clinical diagnosis which includes sterile speculum examination with pooling, ferning, and nitrazine tests, or the Amnisure ROM Test

- Planned inpatient expectant management with delivery goal >=7 days from enrollment

- Ability to provide informed consent in English or Spanish

No

Exclusion Criteria

- Imminent delivery

- Transverse or footling breech presentation (if multiple gestation, presenting fetus)

- Unstable lie (if multiple gestation, presenting fetus)

- Funic presentation (if multiple gestation, presenting fetus)

- Active vaginal bleeding

- Regular, painful contractions (>=3 in 10 minutes for 30 minutes or more) consistent with labor

- Clinical contraindication to ambulation as determined by the managing physician

- Physician declines to have the patient approached for participation

- Lethal fetal anomalies

Locations

Location

Status