Plain English Summary
Background and study aims
When a mother is giving birth, if the baby is looking upward instead of downwards in the womb it is harder for the baby to be delivered. The mother is known to have to push longer, and there is an increased chance that the mother will have to have help delivering her baby with, for example, a c-section , forceps or vacuum delivery. There is also an increased chance that she will have severe tears to her vagina. Rotating the baby's head by the hand of the physician is one way to turn the baby to the easier "looking down" position. This study looks whether trying to rotate the baby at the beginning of the pushing stage of labor would make for an easier delivery for the baby and mother. Specifically, the study investigates how long it takes the mother to push the baby out (in what is called the second stage of labor), the risk of severe tears to the vagina, and the likelihood of whether a c-section, forceps or vacuum delivery is necessary when comparing one group of mothers that were allowed to start pushing without rotating the baby, and another where rotation was tried at the start of pushing.
Who can participate?
Mothers (aged at least 18) giving birth for the first time with babies that are full term.
What does the study involve?
Participants are randomly allocated to one of two groups. For those in group 1, rotation of the baby is attempted before they are allowed to start pushing. Those in group 2 are allowed to start pushing before the baby is rotated. All participants are assessed see how long the second stage of labor takes, type of delivery they undergo (was it vaginal or c-section for example), and whether the mothers suffer from any severe tearing of the vagina.
What are the possible benefits and risks of participating?
Benefits of the study includes a reduction in how long the second stage of labor takes and an easier delivery of the child. Possible risks include injury to the baby's head from the rotation, or risk of the umbilical cord coming down in front of the baby's head during the rotation which would require an urgent c/section. Prior studies have showed that these complications are very rare.
Where is the study run from?
Utah Valley Regional Medical Center (USA)
When is the study starting and how long is it expected to run for?
June 2009 to September 2012
Who is funding the study?
Investigator initiated and funded (USA)
Who is the main contact?
Dr Jeff Broberg
broberg@valleyobgynutah.com
Trial website
Contact information
Type
Public
Primary contact
Dr Jeff Broberg
ORCID ID
Contact details
Valley Obstetrics and Gynecology
585 North 500 West
Provo
Utah
84604
United States of America
8013741801
broberg@valleyobgynutah.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMS# 1014958
Study information
Scientific title
A randomized controlled trial of prophylactic early manual rotation of the occiput posterior fetus at the beginning of the second stage vs. expectant management
Acronym
EMR
Study hypothesis
Rotation of the fetal head at the beginning of the second stage of labor in nulliparous women will decrease the time of maternal pushing, as compared to women who pushed without rotation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Prolonged second stage of labor
Intervention
Nulliparous women at term having their first vaginal delivery were randomized to either:
1. Attempted early manual rotation of the fetus or
2. Expectant management
The expectant management group could be rotated later in the second stage for other indications (arrest of descent or for other maternal or fetal indications)
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Length of the second stage of labor - measured in minutes from the time pushing was initiated until delivery of the baby, as documented in the delivery record by labor and delivery nursing staff.
Secondary outcome measures
1. Operative delivery - delivery method recorded as spontaneous vaginal delivery, operative vaginal delivery (forceps or vacuum), or cesarean delivery.
2. 3rd or 4th degree laceration rate - recorded as on the delivery record as assessed by the delivery physician at the time of delivery.
All assessed at the time of delivery, recorded by the delivering doctor at the time provider is filling out the delivery record.
Overall trial start date
01/06/2009
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. At least18 years old
2. Having first vaginal delivery
3. Term gestation (more than 37 weeks gestation)
4. Must have reassuring fetal status and maternal status
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Preterm
2. Non reassuring fetal or maternal status
3. Multiparous
Recruitment start date
01/01/2010
Recruitment end date
30/06/2012
Locations
Countries of recruitment
United States of America
Trial participating centre
Utah Valley Regional Medical Center (Intermountain Health Care)
84604
United States of America
Funders
Funder type
Hospital/treatment centre
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Paper has been recently presented as an oral presentation at the Society of Maternal Fetal Medicine Conference in Atlanta, Georgia, February 2016. Paper is being prepared to be submitted to the American Journal of Obstetrics and Gynecology.
Intention to publish date
01/06/2016
Participant level data
Available on request
Results - basic reporting
Publication summary