Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.NCT02080429
Passive Descent in Obese Nulliparous Gravidae
A study testing Passive Descent and Pushing in people with Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing., run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
Obesity rates in reproductive aged women in the United States are rising. It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.
- What is being tested?
- Passive Descent and Pushing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2015
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)] greater than or equal to 30 as determined at the time of admission to labor and delivery
- Regional anesthesia
- Nulliparous (defined as no deliveries after 20 weeks gestation)
- Gestational age of 37 0/7 weeks and greater
- Singleton Pregnancy
Who cannot join
- Body mass index (BMI) calculated as weight (kg)/ [height (m2)] less than 30 as determined at the time of admission to labor and delivery
- No regional anesthesia
- Multiparous
- Gestational age of less than 37 0/7 weeks
- Multiple gestations
- Maternal fever prior to second stage
- Severe fetal anomalies (incompatible with life)
Trial locations and contacts
1 site in 1 country.
Alisse Hauspurg, MD contact
United States1 site
Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?
Obesity rates in reproductive aged women in the United States are rising. It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section. Recent studies have also shown an increased rate of cesarean section in obese women, adding to the already elevated rate of complications and adverse outcomes. Given the increased a priori risk for obese patients, it is vital that the investigators reexamine management practices routinely used for normal weight women in this specific high-risk population. Passive descent has been shown to increase the spontaneous vaginal delivery rate in non-obese women; however, high quality studies have never been performed in obese women. the investigators hypothesize that passive descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with regional anesthesia. This study will randomize women to passive descent for ninety minutes or active pushing upon entry into the second stage. Further, given that passive descent is widely accepted in the midwifery literature and clinical practice, the investigators anticipate that a high-quality study in the physician literature could increase the dialogue between practitioners and lead to development of best practices in this high-risk population.
- Being tested
- Passive Descent, Pushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive DescentProcedure or surgery
PushingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate Pushing | Active comparator | Patient's will begin to push when they are determined to be completely dilated. Receives: Procedure: Pushing |
| Passive Descent | Experimental | Patient's will wait 90 minutes prior to begin pushing Receives: Procedure: Passive Descent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of spontaneous vaginal delivery
Measured: At delivery
Secondary outcomes (4)
Rate of infections (defined as fever and / or antibiotic initiation)
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Rate of Third and Fourth Degree Lacerations
Measured: At delivery
Rate of Postpartum Hemorrhage
Measured: At delivery
Neonatal Outcomes
- admission to NICU
- umbilical cord pH <7.1
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alisse Hauspurg, Women and Infants Hospital of Rhode Island
- Investigators
- Alisse Hauspurg, MD, Principal investigator, Women & Infant's HospitalErika Werner, MD, Study director, Women & Infant's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080429
- Sponsor's protocol ID
- WIHRI-PD
- Status last verified
- Mar 2014
- First submitted
- 3 Mar 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?
- ClinicalTrials.gov ID
- NCT02080429
- Acronym / sponsor ID
- WIHRI-PD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Primary completion
- Jun 2015 (estimated)
- First posted
- 6 Mar 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.
Obesity rates in reproductive aged women in the United States are rising. It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section. Recent studies have also shown an increased rate of cesarean section in obese women, adding to the already elevated rate of complications and adverse outcomes. Given the increased a priori risk for obese patients, it is vital that the investigators reexamine management practices routinely used for normal weight women in this specific high-risk population. Passive descent has been shown to increase the spontaneous vaginal delivery rate in non-obese women; however, high quality studies have never been performed in obese women. the investigators hypothesize that passive descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with regional anesthesia. This study will randomize women to passive descent for ninety minutes or active pushing upon entry into the second stage. Further, given that passive descent is widely accepted in the midwifery literature and clinical practice, the investigators anticipate that a high-quality study in the physician literature could increase the dialogue between practitioners and lead to development of best practices in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Pushing | Active comparator | Procedure: PushingPatient's will begin to push when they are determined to be completely dilated. |
| Passive Descent | Experimental | Procedure: Passive DescentPatient's will wait 90 minutes prior to begin pushing |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)] greater than or equal to 30 as determined at the time of admission to labor and delivery
- Regional anesthesia
- Nulliparous (defined as no deliveries after 20 weeks gestation)
- Gestational age of 37 0/7 weeks and greater
- Singleton Pregnancy
Key exclusion criteria (7 listed)
- Body mass index (BMI) calculated as weight (kg)/ [height (m2)] less than 30 as determined at the time of admission to labor and delivery
- No regional anesthesia
- Multiparous
- Gestational age of less than 37 0/7 weeks
- Multiple gestations
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 |
|---|---|---|
| Passive Descent | Procedure or surgery | Passive Descent |
| Pushing | Procedure or surgery | Immediate Pushing |
Primary outcome
Rate of spontaneous vaginal delivery
Time frame: At delivery
4 secondary outcomes
Rate of infections (defined as fever and / or antibiotic initiation)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Rate of Third and Fourth Degree Lacerations
Time frame: At delivery
Rate of Postpartum Hemorrhage
Time frame: At delivery
Neonatal Outcomes
Time frame: At delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
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.
Alisse Hauspurg, MD contact
Alisse Hauspurg, MD principal investigator
Women & Infant's Hospital
Erika Werner, MD study director
Women & Infant's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Descent and Pushing in people with Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing., run by Women and Infants Hospital of Rhode Island 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alisse Hauspurg, MD (ahauspurg@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of spontaneous vaginal delivery (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2014.