NCT07653334

Brief Summary

This study aims to understand whether informing laboring patients about how long they have been pushing during the second stage of labor affects the length of that stage and the overall childbirth experience. The second stage of labor is the period from when the cervix is fully dilated until the baby is delivered. When this stage lasts longer than expected, it can increase the chance of complications such as assisted delivery with vacuum or forceps, cesarean delivery, heavy bleeding after delivery, and certain neonatal complications. Although healthcare providers routinely track the duration of the second stage, patients are not always told how long they have been pushing. Some providers believe that sharing this information may help motivate patients and improve their sense of control, while others worry that it could increase stress or pressure. In this study, participants will be randomly assigned to one of two groups. In the intervention group, patients will receive regular updates about how long they have been pushing during the second stage of labor, and a visible timer will be used. In the comparison group, patients will receive standard care, which does not include structured time updates. All participants will receive the same medical care otherwise. The study will measure the length of the second stage of labor as well as maternal and neonatal outcomes such as the type of delivery, postpartum complications, newborn health indicators, and admission to the neonatal intensive care unit. Participants will also be asked to complete a short questionnaire after delivery about their childbirth experience and sense of control during labor. The risks of this study are minimal because the intervention involves only providing information about time during labor. There are no changes to medical treatment or standard care. The information gained from this research may help clinicians improve communication with patients during labor and may identify simple ways to enhance patient experience and potentially improve labor outcomes. Participation in the study is voluntary, and patients may decline or withdraw at any time without affecting the care they receive.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 1, 2026

Last Update Submit

June 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean difference of the duration of the second stage of labor

    The duration of the second stage will be recorded from the time of full cervical dilation to the expulsion of the neonate.

    From complete cervical dilation(10cm-which is the start of the second stage) to delivery of the neonate(either spontaneously or operative vaginal delivery), or cessation of pushing for cesarean delivery, maximum of 4 hours from complete cervical dilation

  • Duration of the second stage of labor

    How long it took from full cervical dilatation to delivery of the fetus

    full cervical dilatation to expulsion of the fetus

Secondary Outcomes (9)

  • Maternal satisfaction and perceived control

    Within 48 hours postpartum

  • Maternal self-report exhaustion

    within 24 hours postpartum

  • Degree of perineal laceration.

    Within 10-minutes from the delivery of the placenta

  • 5-minute APGAR score

    5 minutes after delivery of neonate.

  • Umbilical artery pH

    Sample collection: 0 to 5 minutes from resection of the umbilical cord. Analyzed within 60 minutes of collection.

  • +4 more secondary outcomes

Other Outcomes (1)

  • Postpartum endometritis

    Time of delivery to discharge of mother( within 96 hours after delivery)

Study Arms (2)

Time awareness

EXPERIMENTAL

Participants randomized to the intervention arm will receive structured awareness of the duration of the second stage of labor. At complete cervical dilation, a nurse or provider will initiate an electronic timer and inform the participant that elapsed pushing time will be monitored and communicated throughout the second stage. The timer will be visible to the participant. Standardized verbal updates on elapsed time will be provided every 30 minutes, with additional reminders at clinically relevant thresholds based on parity and neuraxial analgesia status. Feedback will be supportive, non-coercive, and focused on encouragement and shared decision-making. The intervention is intended to increase maternal awareness of labor progress without changing clinical management. All other aspects of care, including labor positioning, coaching, analgesia, fetal monitoring, and decisions regarding operative vaginal delivery or cesarean delivery, will follow standard institutional protocols.

Behavioral: Time aware

Usual care

NO INTERVENTION

Participants randomized to the usual care arm will receive standard obstetric management during the second stage of labor. Clinicians will manage the second stage according to routine clinical practice, but no structured or protocolized communication regarding elapsed pushing time will be provided. Participants will not have access to the study timer, and healthcare providers will not be instructed to provide scheduled updates on the duration of the second stage. Any communication regarding labor progress will occur at the discretion of the clinical team and in accordance with standard practice. All other aspects of care, including labor support, maternal positioning, pushing techniques, pain management, fetal monitoring, and decisions regarding operative vaginal delivery or cesarean delivery, will be managed according to existing institutional protocols and provider judgment.

Interventions

Time awareBEHAVIORAL

Participants randomized to the intervention arm will receive structured awareness of the duration of the second stage of labor. At complete cervical dilation, a nurse or provider will initiate an electronic timer and inform the participant that elapsed pushing time will be monitored and communicated throughout the second stage. The timer will be visible to the participant. Standardized verbal updates on elapsed time will be provided every 30 minutes, with additional reminders at clinically relevant thresholds based on parity and neuraxial analgesia status. Feedback will be supportive, non-coercive, and focused on encouragement and shared decision-making. The intervention is intended to increase maternal awareness of labor progress without changing clinical management. All other aspects of care, including labor positioning, coaching, analgesia, fetal monitoring, and decisions regarding operative vaginal delivery or cesarean delivery, will follow standard institutional protocols.

Time awareness

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton, cephalic presentation
  • Gestational age ≥ 37+0 weeks at delivery.
  • Reached the second stage of labor (complete cervical dilation with intention to proceed with vaginal delivery).
  • Ability to understand study information and provide informed consent.

You may not qualify if:

  • Planned cesarean delivery.
  • Intrauterine fetal demise.
  • Critical maternal illness requiring intensive hemodynamic or respiratory support.
  • Cognitive impairment or language barrier precluding consent and comprehension of instructions.
  • Abnormal fetal heart tracing requiring operative vaginal delivery
  • Shoulder dystocia requiring maneuvers other than McRoberts and suprapubic pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • McCormick A, Meijen C, Anstiss PA, Jones HS. Self-regulation in endurance sports: theory, research, and practice. Int Rev Sport Exerc Psychol. 2019;12(1):235-264. doi:10.1080/1750984X.2018.1469161

    BACKGROUND
  • Allen VM, Baskett TF, O'Connell CM, McKeen D, Allen AC. Maternal and perinatal outcomes with increasing duration of the second stage of labor. Obstet Gynecol. 2009 Jun;113(6):1248-1258. doi: 10.1097/AOG.0b013e3181a722d6.

    PMID: 19461419BACKGROUND
  • Rouse DJ, Weiner SJ, Bloom SL, Varner MW, Spong CY, Ramin SM, Caritis SN, Peaceman AM, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Harper M, Iams JD, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Second-stage labor duration in nulliparous women: relationship to maternal and perinatal outcomes. Am J Obstet Gynecol. 2009 Oct;201(4):357.e1-7. doi: 10.1016/j.ajog.2009.08.003.

    PMID: 19788967BACKGROUND
  • Laughon SK, Berghella V, Reddy UM, Sundaram R, Lu Z, Hoffman MK. Neonatal and maternal outcomes with prolonged second stage of labor. Obstet Gynecol. 2014 Jul;124(1):57-67. doi: 10.1097/AOG.0000000000000278.

    PMID: 24901265BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Valmiki Vijay Seeraj, MD

    Bronxcare Healthcare System

    PRINCIPAL INVESTIGATOR
  • Emmanuel Afful, MD, MPH

    Bronxcare Healthcare System

    STUDY DIRECTOR

Central Study Contacts

Emmanuel Afful, MD, MPH

CONTACT

Valmiki Vijay Seeraj, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to either structured maternal awareness of second-stage duration or usual care. Participants in both groups will be followed concurrently, and outcomes will be compared between groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Program Director, Obstetrics and Gynecology

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

June 17, 2026

Record last verified: 2026-06