Preterm Premature Rupture of the MembranesPACTNCT02327637
A Comparison of Bed Rest Versus Moderate Activity in Preterm Premature Rupture of Membranes (PPROM)
A study testing Moderate Activity in people with Preterm Premature Rupture of the Membranes and Physical Activity, run by University of California, San Diego at 1 site in United States.
Trial summary
Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Premature Rupture of the Membranes, Physical Activity
- What is being tested?
- Moderate Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 12 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant
- Gestational age between 23 weeks 0 days - 32 weeks 0 days
- Diagnosed with preterm premature rupture of membranes
Who cannot join
- Cervical dilation greater than or equal to 3cm
- Active labor
- Evidence of infection
- Inability to provide informed consent
- Requirement for continuous fetal monitoring
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Health Sciences, Labor & Delivery
San Diego, California, 92103
About this study
Official title: A Comparison of Bed Rest Versus Moderate Activity Among Inpatient Antepartum Patients With Preterm Premature Rupture of Membranes (PPROM): A Randomized Controlled Trial
Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. In this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (PPROM).
Read the detailed description
Historically, bed rest has been considered a beneficial treatment option for patients with high risk pregnancies. The definition of bed rest varies between providers, and can mean anything from being completely bed-bound for months at a time (sometimes called strict bed rest) to walking around within the home a few times a day (sometimes called modified bed rest). Recent studies have highlighted potential harmful effects from bed rest. However, scientific studies need to be carried out to compare the effects of bed rest and moderate activity on the health of mothers and babies.
PPROM is defined as rupture of membranes prior to 37 weeks gestation prior to the onset of labor, and affects approximately 3% of all pregnancies in the Unites States. Women with PPROM are routinely managed in the inpatient setting from the time of diagnosis until delivery. Therefore, PPROM patients are a closely supervised and easily accessible cohort of women.
In this study, participating patients with PPROM will be randomized into two groups: bedrest or moderate activity. Maternal mood and muscle strength will be assessed at enrollment and after delivery to determine whether there are significant differences in these outcomes in the two groups.
- Being tested
- Moderate Activity
- Keywords
- Preterm Premature Rupture of the Membranes, Bedrest, Physical Activity
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate ActivityBehavioural
Ambulation 150 feet, two times per day
| Study group | Role | What they receive |
|---|---|---|
| Bedrest | No intervention | Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following: 1. Receive recommendation for bedrest (standard of care). 2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). 3. Wear a pedometer to measure activity when out of bed (observational study procedure). |
| Moderate Activity | Experimental | Subjects randomized to this arm of the study will undergo the following:
1. Receive recommendation to ambulate 150 feet, twice per day (interventional study procedure). Prior to each session of ambulation, an ultrasound will be performed to ensure adequate amniotic fluid volume and appropriate fetal position, and a fetal heart rate tracing will be obtained to ensure that there is reassuring fetal status (observational study procedure). During each session of ambulation, the fetal heart rate tracing will be monitored continuously (observational study procedure).
2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure).
3. Wear a pedometer to measure activity when out of bed (observational study procedure). Receives: Behavioral: Moderate Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Depression Score
Maternal Depression Score as measured by the Edinburg Postpartum Depression Scale will be determined at the time of enrollment and after delivery.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (2)
Change in Maternal Anxiety Score
Maternal Anxiety Score as measured by the State-Trait Anxiety Inventory will be determined at the time of enrollment and after delivery.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Change in Maternal Muscle Strength
Maternal Muscle Strength as measured by semi-quantitative muscle strength testinging will be determined at the time of enrollment and after delivery.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of the MembranesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis, University of California, Irvine, University of California, Los Angeles
- Responsible party
- Principal investigator, Louise Laurent, MD/PhD, University of California, San Diego
- Investigators
- Louise C Laurent, MD/PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327637
- Sponsor's protocol ID
- 140455
- Acronym
- PACT
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
PubMed 21508700Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol. 2003 Jan;101(1):178-93. doi: 10.1016/s0029-7844(02)02366-9.
PubMed 12517665Koonings PP, Paul RH, Campbell K. Umbilical cord prolapse. A contemporary look. J Reprod Med. 1990 Jul;35(7):690-2.
PubMed 2376856Fox NS, Gelber SE, Kalish RB, Chasen ST. The recommendation for bed rest in the setting of arrested preterm labor and premature rupture of membranes. Am J Obstet Gynecol. 2009 Feb;200(2):165.e1-6. doi: 10.1016/j.ajog.2008.08.007. Epub 2008 Nov 18.
PubMed 19019329Kendall PC, Finch AJ Jr, Auerbach SM, Hooke JF, Mikulka PJ. The State-Trait Anxiety Inventory: a systematic evaluation. J Consult Clin Psychol. 1976 Jun;44(3):406-12. doi: 10.1037//0022-006x.44.3.406. No abstract available.
PubMed 932270
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Bed Rest Versus Moderate Activity Among Inpatient Antepartum Patients With Preterm Premature Rupture of Membranes (PPROM): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02327637
- Acronym / sponsor ID
- PACT / 140455
- Keywords
- Preterm Premature Rupture of the Membranes, Bedrest, Physical Activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis, University of California, Irvine, University of California, Los Angeles
- Study start
- Dec 2014
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. In this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (PPROM).
Detailed description
Historically, bed rest has been considered a beneficial treatment option for patients with high risk pregnancies. The definition of bed rest varies between providers, and can mean anything from being completely bed-bound for months at a time (sometimes called strict bed rest) to walking around within the home a few times a day (sometimes called modified bed rest). Recent studies have highlighted potential harmful effects from bed rest. However, scientific studies need to be carried out to compare the effects of bed rest and moderate activity on the health of mothers and babies.
PPROM is defined as rupture of membranes prior to 37 weeks gestation prior to the onset of labor, and affects approximately 3% of all pregnancies in the Unites States. Women with PPROM are routinely managed in the inpatient setting from the time of diagnosis until delivery. Therefore, PPROM patients are a closely supervised and easily accessible cohort of women.
In this study, participating patients with PPROM will be randomized into two groups: bedrest or moderate activity. Maternal mood and muscle strength will be assessed at enrollment and after delivery to determine whether there are significant differences in these outcomes in the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedrest | No intervention | –Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following: 1. Receive recommendation for bedrest (standard of care). 2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). 3. Wear a pedometer to measure activity when out of bed (observational study procedure). |
| Moderate Activity | Experimental | Behavioral: Moderate ActivitySubjects randomized to this arm of the study will undergo the following: 1. Receive recommendation to ambulate 150 feet, twice per day (interventional study procedure). Prior to each session of ambulation, an ultrasound will be performed to ensure adequate amniotic fluid volume and appropriate fetal position, and a fetal heart rate tracing will be obtained to ensure that there is reassuring fetal status (observational study procedure). During each session of ambulation, the fetal heart rate tracing will be monitored continuously (observational study procedure). 2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). 3. Wear a pedometer to measure activity when out of bed (observational study procedure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- Gestational age between 23 weeks 0 days - 32 weeks 0 days
- Diagnosed with preterm premature rupture of membranes
Key exclusion criteria (5 listed)
- Cervical dilation greater than or equal to 3cm
- Active labor
- Evidence of infection
- Inability to provide informed consent
- Requirement for continuous fetal monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate ActivityAmbulation 150 feet, two times per day | Behavioural | Moderate Activity |
Primary outcome
Change in Maternal Depression Score
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Maternal Depression Score as measured by the Edinburg Postpartum Depression Scale will be determined at the time of enrollment and after delivery.
2 secondary outcomes
Change in Maternal Anxiety Score
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Change in Maternal Muscle Strength
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Background: PubMed 21508700Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
- Background: PubMed 12517665Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol. 2003 Jan;101(1):178-93. doi: 10.1016/s0029-7844(02)02366-9.
- Background: PubMed 2376856Koonings PP, Paul RH, Campbell K. Umbilical cord prolapse. A contemporary look. J Reprod Med. 1990 Jul;35(7):690-2.
- Background: PubMed 19019329Fox NS, Gelber SE, Kalish RB, Chasen ST. The recommendation for bed rest in the setting of arrested preterm labor and premature rupture of membranes. Am J Obstet Gynecol. 2009 Feb;200(2):165.e1-6. doi: 10.1016/j.ajog.2008.08.007. Epub 2008 Nov 18.
- Background: PubMed 932270Kendall PC, Finch AJ Jr, Auerbach SM, Hooke JF, Mikulka PJ. The State-Trait Anxiety Inventory: a systematic evaluation. J Consult Clin Psychol. 1976 Jun;44(3):406-12. doi: 10.1037//0022-006x.44.3.406. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise C Laurent, MD/PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Activity in people with Preterm Premature Rupture of the Membranes and Physical Activity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal Depression Score (time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327637, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.