Steps to Extend Latency in Preterm Prelabor Rupture of Membranes (STEP)
The goal of this quasi-experimental study is to determine if there are improved outcomes for patients with preterm prelabor rupture of membranes (PPROM) who walk daily. The main question it aims to answer is:
- Are patients with PPROM who walk at least 3500 steps per day more likely to stay pregnant longer than those who walk less?
Participants will be encouraged to walk ≥3500 steps per day from the time of diagnosis until delivery and their daily step counts will be recorded. Researchers will compare those who actually walk ≥3500 steps per day to those who walk less.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The primary objective of this study is to determine if there is increased latency to delivery for patients with PPROM who ambulate ≥3500 steps per day compared to those who ambulate less. The investigators have chosen a goal of 3500 steps as this equates to approximately 30 minutes of moderate-intensity walking, and ACOG endorses the US Department of Health and Human Services Physical Activity Guidelines which recommend at least 150 minutes of moderate intensity aerobic activity per week during pregnancy.
The secondary objective of this study is to determine whether there is a lower risk of adverse maternal and neonatal outcomes for patients with PPROM who ambulate ≥3500 steps per day compared to those who ambulate less. Maternal adverse outcomes that will be assessed include rate of intra-amniotic infection, placental abruption, umbilical cord prolapse, cesarean delivery for non-reassuring fetal heart tracing, and thromboembolic events. Neonatal adverse outcomes that will be assessed include gestational age at delivery, birth weight, APGAR score at 5 minutes, requirement for NICU admission, length of stay, and neonatal death. The investigators will also assess the average steps per day for each participant and type of smartphone (i.e. Android vs iPhone).
Inclusion criteria include patients admitted to Cedars-Sinai with PPROM between the gestational ages of 24w0d and 33w6d who have planned inpatient management of at least 7 days, a phone capable of monitoring and sharing step count, and a singleton or dichorionic twin gestation. Exclusion criteria include patients with malpresentation (specifically, transverse, footling breech, or funic presentation), active preterm labor, or active vaginal bleeding.
This is a quasi-experimental study. All patients will be encouraged to ambulate ≥3500 steps per day. Patients will then be categorized into two cohorts: those who ambulated ≥3500 steps per day and those who ambulated <3500 steps per day. Outcomes will be compared between the two cohorts.
The duration of the study for each patient is the length of time from admission to delivery.
The study will be conducted at one site only, Cedars-Sinai.
At the time of study recruitment, patients will be given information about exercise in pregnancy and encouraged to ambulate at least 3500 steps per day. They will also be asked to share their daily step count via their smartphone health app with a member of the research team. All other antepartum, intrapartum, and postpartum care will be standard and/or per the primary obstetrician's discretion. After hospital discharge, a member of the research team will record the patient's daily step count and extract demographic information as well as obstetric and neonatal outcomes from the EMR.
Our primary outcome is the mean number of days of latency to delivery, and the investigators will use a Welch's t-test to assess the difference between our two study groups. The investigators will then use a multivariable linear regression analysis to account for potentially confounding variables.
For our secondary outcomes, the investigators will assess time from diagnosis to delivery using a log-rank test followed by a cox regression analysis. Additionally, maternal demographic and obstetric outcomes as well as neonatal outcomes will be compared using chi square and t-test for categorical and continuous variables, respectively.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Glenda Marshall, MD
- 전화번호: 4243244193
- 이메일: glenda.marshall@cshs.org
연구 연락처 백업
- 이름: Gabriela Dellapiana, MD
- 전화번호: 3104237417
연구 장소
-
-
California
-
Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Center
-
연락하다:
- Glenda Marshall, MD
- 전화번호: 4243244193
- 이메일: glenda.marshall@cshs.org
-
연락하다:
- Gabriela Dellapiana, MD
- 전화번호: 3104237417
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Planned inpatient expectant management of ≥7 days
- Phone capable of monitoring and sharing step count
- Singleton or dichorionic twin gestation
Exclusion Criteria:
- Any records flagged "break the glass" or "research opt out"
- Transverse, footling breech, or funic presentations
- Active preterm labor
- Active vaginal bleeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Encouraged to Ambulate
All patients will be encouraged to ambulate ≥3500 steps per day |
Ambulate ≥3500 steps per day |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Days of latency until delivery
기간: From hospital admission to delivery
|
From hospital admission to delivery
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants who experience a thromboembolic event
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of participants who experience a postpartum hemorrhage
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
Postpartum hemorrhage is defined as EBL/QBL >= 1000mL |
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
Number of participants who experience maternal sepsis
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of participants who are admitted to the Intensive Care Unit (ICU)
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Days of postpartum length of stay
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Mode of delivery
기간: Day of delivery
|
Vaginal delivery versus cesarean section |
Day of delivery
|
|
Estimated or quantitative delivery blood loss
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of participants who experience an intraamniotic infection
기간: From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of patients who experience a placental abruption
기간: From admission until delivery
|
From admission until delivery
|
|
|
Number of patients who experience an umbilical cord prolapse
기간: From admission until delivery
|
From admission until delivery
|
|
|
Spontaneous versus induced labor
기간: From admission until delivery
|
From admission until delivery
|
|
|
Indication for cesarean delivery
기간: Day of delivery
|
Only for patients who deliver via cesarean delivery |
Day of delivery
|
|
Gestational age at delivery
기간: Day of delivery
|
Day of delivery
|
|
|
Neonatal birth weight
기간: Day of delivery
|
Day of delivery
|
|
|
APGAR score at 5 minutes of life
기간: 5 minutes of life on day of delivery
|
APGAR score (Appearance, Pulse, Grimace, Activity, and Respiration) is on a scale from 0-10. Lower scores indicate that infants are more likely to require resuscitation. |
5 minutes of life on day of delivery
|
|
Umbilical cord blood gas values
기간: Day of delivery
|
Arterial pH, CO2, and base excess |
Day of delivery
|
|
Number of neonates who require Neonatal Intensive Care Unit (NICU) admission
기간: From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
|
|
Neonatal length of hospital stay
기간: From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
|
|
Number of participants who receive at least one course of antenatal corticosteroids
기간: From admission until delivery
|
From admission until delivery
|
|
|
Number of participants who receive antenatal magnesium sulfate
기간: From admission until delivery
|
From admission until delivery
|
|
|
Number of neonatal deaths
기간: From admission until day of neonatal hospital discharge (or death when applicable), varies based on gestational age at delivery
|
From admission until day of neonatal hospital discharge (or death when applicable), varies based on gestational age at delivery
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Gabriela Dellapiana, MD, Cedars-Sinai Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY00004892
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
To protect patient confidentiality
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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