Labor, Second StageNCT07653334
Effect of Maternal Awareness of the Duration fo the Second Stage of Labor on the Length of the Second Stage
A study testing Time aware in people with Labor, Second Stage and Motivation, run by Valmiki Vijay Seeraj.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Second Stage, Motivation, Feedback, Psychological
- What is being tested?
- Time aware
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Maternal Awareness of the Duration fo the Second Stage of Labor on the Length of the Second Stage: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Background and Rationale The second stage of labor, defined as the interval from complete cervical dilation to delivery of the fetus, is a critical phase of childbirth with important implications for maternal and neonatal outcomes. Prolonged second stage of labor has been associated with increased risks of operative vaginal delivery, cesarean delivery, postpartum hemorrhage, severe perineal lacerations, chorioamnionitis, and neonatal morbidity, including low Apgar scores and neonatal intensive care unit (NICU) admission. As a result, contemporary obstetric guidelines provide time-based thresholds to define prolonged second stage, often stratified by parity and use of neuraxial analgesia.
Despite the centrality of time thresholds in clinical decision-making, clinicians typically monitor second-stage and are recommended to continuously communicate with the parturient[a]. While some providers may offer general reassurance ("you're making progress"), others may avoid discussing time altogether, out of concern that emphasizing elapsed duration could increase anxiety, fatigue, or a sense of pressure. Consequently, the extent to which parturients are aware of the duration of the second stage varies widely and is largely unstructured.
Patient engagement and shared decision-making have increasingly been recognized as important components of high-quality obstetric care. In non-obstetric clinical settings, real-time feedback and awareness of performance metrics-such as elapsed time, distance, or workload-have been shown to influence behavior, motivation, and outcomes. In labor, behavioral factors such as maternal effort, positioning, coping strategies, perceived control, and coached pushing may plausibly affect the effectiveness of pushing and overall labor progress. However, the specific role of maternal awareness of elapsed time during the second stage of labor has not been systematically studied.
Existing literature on second-stage management has largely focused on physiologic versus directed pushing, delayed versus immediate pushing, maternal positioning, and clinician-led coaching strategies. While these studies provide important insights, they do not address whether informing the laboring person about the duration of the second stage-without altering clinical management-affects the second stage's length.
Importantly, maternal experience and satisfaction are increasingly recognized as meaningful outcomes in obstetric research. A sense of control, understanding of the labor process, and effective communication have been associated with greater satisfaction with childbirth and a reduced risk of negative birth experiences. Whether structured communication about second-stage duration enhances or detracts from these aspects of the birth experience remains unknown.
Given the lack of high-quality evidence on this topic, a randomized controlled trial is needed to evaluate the impact of structured maternal awareness of second-stage duration on second-stage labor duration and related maternal and neonatal outcomes. Such evidence would directly inform clinical communication practices during labor and could offer a low-cost, easily scalable intervention to optimize labor outcomes while supporting patient-centered care.
- Objectives and Hypotheses Primary Objective To determine whether structured maternal awareness of the duration of the second stage of labor reduces the length of the second stage of labor compared with usual care.
Secondary Objectives
- To assess the impact of the intervention on:
- Mode of delivery (spontaneous vaginal vs operative vaginal vs cesarean delivery in the second stage).
- Maternal outcomes: perineal laceration degree, postpartum hemorrhage, maternal exhaustion, need for operative assistance.
- Neonatal outcomes: 5-minute Apgar score, umbilical artery pH (if available), NICU admission.
- Maternal satisfaction with the birth experience and perceived sense of control.
- To evaluate whether the effect of the intervention differs by parity and use of neuraxial analgesia. Hypotheses
- Primary hypothesis: Women who receive structured feedback about the elapsed duration of the second stage will have a shorter median second stage of labor than women receiving usual care.
- Secondary hypotheses:
- The intervention will not worsen maternal or neonatal morbidity.
- Maternal satisfaction and perceived control will be higher in the intervention group.
- Study Design A single-center, parallel-group, randomized controlled trial with a 1:1 allocation ratio.
- Setting The trial will be conducted on the Labor and Delivery unit of Bronxcare, a community hospital with approximately 1500 births per year.
- Conditions
- Labor, Second Stage, Motivation, Feedback, Psychological, Self Efficacy, Personal Satisfaction, Perception
- Being tested
- Time aware
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time awareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: full cervical dilatation to expulsion of the fetus
Secondary outcomes (9)
Maternal satisfaction and perceived control
The Labor agentry scale scored from 10-70. Higher scores indicate greater sense of autonomy, empowerment, and active involvement during labor. Lower scores indicate helplessness, a loss of control, or feeling overwhelmed by the birthing process.
Measured: Within 48 hours postpartum
Maternal self-report exhaustion
A likert scale to assess maternal exhaustion
Measured: within 24 hours postpartum
Degree of perineal laceration.
First-degree tear: superficial skin or vaginal mucosal laceration Second-degree tear: laceration extends through underlying perineal muscles but no sphincter involvement.
Third-degree tear: laceration extends to external and or internal anal spincters but not the rectal mucosa.
Fourth-degree tear: Laceration involves the rectal mucosa
Measured: Within 10-minutes from the delivery of the placenta
5-minute APGAR score
The Apgar score compreises of 5 components, weighed evenly and assigned 0,1,or 2. The components are summed at 5 minutes after delivery of the neonate.
Activity(0= absent; 1= some tone and flexed limbs; 2= active), Pulse( 0= no pulse; 1= less than 10bpm; 2= greater than 100bpm), Grimace( 0= floppy; 1= minimal response; 2=prompt response), Appearance(0= blue or pale; 1= pink body, blue limbs; 2= pink body and limbs), Respiration( 0=absent breathing; 1= slow and irregular breathing; 2= vigorous cry) A score of <7/10 is considered non-reassuring, while 7 or more is considered assuring neonatal status.
Measured: 5 minutes after delivery of neonate.
Umbilical artery pH
The pH of the umbilical artery aspirated from a 10-20cm doubly clamped and resected segment of the umbilical cord. The cord blood will be aspirated with a 2mL Heparin-flushed syringe and immediately transported to the laboratory on ice.
Measured: Sample collection: 0 to 5 minutes from resection of the umbilical cord. Analyzed within 60 minutes of collection.
Neonatal Intensive Care Unit(NICU) admission
Admission of neonate to NICU due to factors associated with the labor and delivery of the neonate.
Measured: From birth to 72 hour after delivery.
Duration of NICU admission
length of stay of admitted neonates to the NICU.
Measured: From birth to 7 days
Quantifiable blood loss
The volume of blood loss after delivery of neonate
Measured: From 0 to 24 hours after delivery of neonate
Mode of delivery
The final mode of delivery:
- Spontaneous vaginal delivery
- Operative vaginal delivery ( forceps or vacuum-assisted vaginal delivery)
- Cesarean delivery
Measured: From full cervical dilation to delivery of neonate( within 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor, Second StageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valmiki Vijay Seeraj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valmiki Vijay Seeraj, Bronxcare Hospital System
- Investigators
- Valmiki Vijay Seeraj, MD, Principal investigator, Bronxcare Healthcare SystemEmmanuel Afful, MD, MPH, Study director, Bronxcare Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653334
- Sponsor's protocol ID
- 04092601
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are not decided on sharing patient's protected information to other researchers who were not declared to the IRB of Bronxcare Healthcare System.
Publications
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
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.
PubMed 19461419Rouse 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.
PubMed 19788967Laughon 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.
PubMed 24901265
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Awareness of the Duration fo the Second Stage of Labor on the Length of the Second Stage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07653334
- Acronym / sponsor ID
- 04092601
- Conditions
- Labor, Second Stage, Motivation, Feedback, Psychological, Self Efficacy, Personal Satisfaction, Perception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Valmiki Vijay SeerajUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- 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.
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.
Detailed description
Background and Rationale The second stage of labor, defined as the interval from complete cervical dilation to delivery of the fetus, is a critical phase of childbirth with important implications for maternal and neonatal outcomes. Prolonged second stage of labor has been associated with increased risks of operative vaginal delivery, cesarean delivery, postpartum hemorrhage, severe perineal lacerations, chorioamnionitis, and neonatal morbidity, including low Apgar scores and neonatal intensive care unit (NICU) admission. As a result, contemporary obstetric guidelines provide time-based thresholds to define prolonged second stage, often stratified by parity and use of neuraxial analgesia.
Despite the centrality of time thresholds in clinical decision-making, clinicians typically monitor second-stage and are recommended to continuously communicate with the parturient[a]. While some providers may offer general reassurance ("you're making progress"), others may avoid discussing time altogether, out of concern that emphasizing elapsed duration could increase anxiety, fatigue, or a sense of pressure. Consequently, the extent to which parturients are aware of the duration of the second stage varies widely and is largely unstructured.
Patient engagement and shared decision-making have increasingly been recognized as important components of high-quality obstetric care. In non-obstetric clinical settings, real-time feedback and awareness of performance metrics-such as elapsed time, distance, or workload-have been shown to influence behavior, motivation, and outcomes. In labor, behavioral factors such as maternal effort, positioning, coping strategies, perceived control, and coached pushing may plausibly affect the effectiveness of pushing and overall labor progress. However, the specific role of maternal awareness of elapsed time during the second stage of labor has not been systematically studied.
Existing literature on second-stage management has largely focused on physiologic versus directed pushing, delayed versus immediate pushing, maternal positioning, and clinician-led coaching strategies. While these studies provide important insights, they do not address whether informing the laboring person about the duration of the second stage-without altering clinical management-affects the second stage's length.
Importantly, maternal experience and satisfaction are increasingly recognized as meaningful outcomes in obstetric research. A sense of control, understanding of the labor process, and effective communication have been associated with greater satisfaction with childbirth and a reduced risk of negative birth experiences. Whether structured communication about second-stage duration enhances or detracts from these aspects of the birth experience remains unknown.
Given the lack of high-quality evidence on this topic, a randomized controlled trial is needed to evaluate the impact of structured maternal awareness of second-stage duration on second-stage labor duration and related maternal and neonatal outcomes. Such evidence would directly inform clinical communication practices during labor and could offer a low-cost, easily scalable intervention to optimize labor outcomes while supporting patient-centered care.
- Objectives and Hypotheses Primary Objective To determine whether structured maternal awareness of the duration of the second stage of labor reduces the length of the second stage of labor compared with usual care.
Secondary Objectives
- To assess the impact of the intervention on:
- Mode of delivery (spontaneous vaginal vs operative vaginal vs cesarean delivery in the second stage).
- Maternal outcomes: perineal laceration degree, postpartum hemorrhage, maternal exhaustion, need for operative assistance.
- Neonatal outcomes: 5-minute Apgar score, umbilical artery pH (if available), NICU admission.
- Maternal satisfaction with the birth experience and perceived sense of control.
- To evaluate whether the effect of the intervention differs by parity and use of neuraxial analgesia. Hypotheses
- Primary hypothesis: Women who receive structured feedback about the elapsed duration of the second stage will have a shorter median second stage of labor than women receiving usual care.
- Secondary hypotheses:
- The intervention will not worsen maternal or neonatal morbidity.
- Maternal satisfaction and perceived control will be higher in the intervention group.
- Study Design A single-center, parallel-group, randomized controlled trial with a 1:1 allocation ratio.
- Setting The trial will be conducted on the Labor and Delivery unit of Bronxcare, a community hospital with approximately 1500 births per year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Time awareness | Experimental | Behavioral: Time awareParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Time awareParticipants 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. | Behavioural | Time awareness |
Primary outcome
Mean difference of the duration of the second stage of labor
Time frame: 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
The duration of the second stage will be recorded from the time of full cervical dilation to the expulsion of the neonate.
Duration of the second stage of labor
Time frame: full cervical dilatation to expulsion of the fetus
How long it took from full cervical dilatation to delivery of the fetus
9 secondary outcomes
Maternal satisfaction and perceived control
Time frame: Within 48 hours postpartum
Maternal self-report exhaustion
Time frame: within 24 hours postpartum
Degree of perineal laceration.
Time frame: Within 10-minutes from the delivery of the placenta
5-minute APGAR score
Time frame: 5 minutes after delivery of neonate.
Umbilical artery pH
Time frame: Sample collection: 0 to 5 minutes from resection of the umbilical cord. Analyzed within 60 minutes of collection.
Neonatal Intensive Care Unit(NICU) admission
Time frame: From birth to 72 hour after delivery.
Duration of NICU admission
Time frame: From birth to 7 days
Quantifiable blood loss
Time frame: From 0 to 24 hours after delivery of neonate
Mode of delivery
Time frame: From full cervical dilation to delivery of neonate( within 4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- BackgroundMcCormick 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: PubMed 19461419Allen 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.
- Background: PubMed 19788967Rouse 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.
- Background: PubMed 24901265Laughon 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.
- Individual participant dataSharing planned: Undecided. We are not decided on sharing patient's protected information to other researchers who were not declared to the IRB of Bronxcare Healthcare System.
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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.
Valmiki Vijay Seeraj, MD principal investigator
Bronxcare Healthcare System
Emmanuel Afful, MD, MPH study director
Bronxcare Healthcare System
Questions about this trial
What is this clinical trial studying?
A study testing Time aware in people with Labor, Second Stage and Motivation, run by Valmiki Vijay Seeraj.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Afful, MD, MPH (718-913-0025, eafful1@bronxcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of the duration of the second stage of labor (time frame: 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). The study lists 2 primary outcomes in all. 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 NCT07653334, which also lists 4 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 17 Jun 2026.