Ambulation for Latency During Expectant Management of PPROM

Pregnancy Complications Clinical Trial

— AMBLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230967
• Other study ID #: HSC-MS-19-0982
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2023
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Pregnancy, High Risk
• Preterm Premature Rupture of the Membranes
• Rupture

Intervention

Behavioral:
• Ambulation Group
Participants in the ambulation arm will be allowed ad lib activity and instructed that they should walk at least once per day out of their room with a goal of 2,000 steps per day. The Fitbit Inspire devices will be set to this goal and notifications will be given on the device for the participants meeting their goals
• Routine Care
No encouragement to ambulate will be provided to subjects. Their movement will be recorded

Locations

Country	Name	City	State
United States	Universtiy of Texas Health Science Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Fitbit Health Solutions, Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency (measured in days) from from randomization to delivery		12 weeks
Secondary	Maternal Infectious morbidity	Chorioamnionitis, endometritis	at delivery
Secondary	# of subjects with Placental abruption		at delivery
Secondary	# of subjects with Cesarean delivery (and emergent cesarean delivery)		at delivery
Secondary	# of subjects with Umbilical cord prolapse		at delivery
Secondary	# of subjects with Maternal venous thromboembolism		at delivery
Secondary	Maternal Readmission		within 6 weeks of delivery- 6 weeks
Secondary	Time to delivery (time-to-event outcome)		12 weeks
Secondary	Delivered at >7 days post randomization		at delivery
Secondary	Maternal antepartum hospitalization length of stay		from admission to delivery
Secondary	Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)	comparison between 2 groups- as measured by validated Stress survey. Scaled 0-4 corresponding response of Never to very often respectively. Change from baseline to day 7	7 days
Secondary	Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)	comparison between 2 groups-as measured by validated anxiety survey. Scaled 1-4 corresponding response of Not at all to very much so. Change from baseline to day 7	7 days
Secondary	Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)	comparison between 2 groups-as measured by validated depression scale. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts) Change from baseline to day 7	7 days
Secondary	Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups	comparison between 2 groups-as measured by validated survey from the last questionnaire answered prior to delivery	at delivery
Secondary	Fetal or neonatal death		at discharge
Secondary	Apgar score < 5 at 5 minutes of life		at delivery
Secondary	Umbilical arterial pH < 7.00		at delivery
Secondary	# of neonates with Small for gestational age	defined as < 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data	at delivery
Secondary	# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV	as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papule classification system	at discharge
Secondary	# of neonates with Neonatal periventricular leukomalacia (PVL)		at discharge
Secondary	# of neonates with Neonatal necrotizing enterocolitis (NEC)		at discharge
Secondary	# of neonates with Neonatal retinopathy of prematurity (ROP).	This diagnosis will be reached when an ophthalmologic examination of the retina has been performed and ROP is diagnosed at Stage I (demarcation line in the retina) or greater.	at discharge
Secondary	# of neonates with Bronchopulmonary dysplasia (BPD)	defined as oxygen requirement at 28 days of life or at 36 weeks postmenstrual age for infants born before 32 weeks.	at discharge
Secondary	Gestational age at delivery < 28 weeks		at delivery
Secondary	Gestational age at delivery < 34 weeks		at delivery
Secondary	Neonatal length of hospital stay, based on admission to NICU or intermediate care unit		at discharge
Secondary	Composite adverse maternal outcome (CMAO)		at discharge
Secondary	Composite adverse fetal/neonatal outcome		at discharge