- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07653334
Effect of Maternal Awareness of the Duration fo the Second Stage of Labor on the Length of the Second Stage
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.
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.
연구 개요
상세 설명
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.
2. 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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Emmanuel Afful, MD, MPH
- 전화번호: 718-913-0025
- 이메일: eafful1@bronxcare.org
연구 연락처 백업
- 이름: Valmiki Vijay Seeraj, MD
- 전화번호: 718-612-2754
- 이메일: vseeraj@bronxcare.org
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Time awareness
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.
|
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.
|
|
간섭 없음: Usual care
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean difference of the duration of the second stage of labor
기간: 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
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The duration of the second stage will be recorded from the time of full cervical dilation to the expulsion of the neonate.
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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
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Duration of the second stage of labor
기간: full cervical dilatation to expulsion of the fetus
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How long it took from full cervical dilatation to delivery of the fetus
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full cervical dilatation to expulsion of the fetus
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maternal satisfaction and perceived control
기간: Within 48 hours postpartum
|
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.
|
Within 48 hours postpartum
|
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Maternal self-report exhaustion
기간: within 24 hours postpartum
|
A likert scale to assess maternal exhaustion
|
within 24 hours postpartum
|
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Degree of perineal laceration.
기간: Within 10-minutes from the delivery of the placenta
|
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 |
Within 10-minutes from the delivery of the placenta
|
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5-minute APGAR score
기간: 5 minutes after delivery of neonate.
|
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. |
5 minutes after delivery of neonate.
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Umbilical artery pH
기간: Sample collection: 0 to 5 minutes from resection of the umbilical cord. Analyzed within 60 minutes of collection.
|
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.
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Sample collection: 0 to 5 minutes from resection of the umbilical cord. Analyzed within 60 minutes of collection.
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Neonatal Intensive Care Unit(NICU) admission
기간: From birth to 72 hour after delivery.
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Admission of neonate to NICU due to factors associated with the labor and delivery of the neonate.
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From birth to 72 hour after delivery.
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Duration of NICU admission
기간: From birth to 7 days
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length of stay of admitted neonates to the NICU.
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From birth to 7 days
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Quantifiable blood loss
기간: From 0 to 24 hours after delivery of neonate
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The volume of blood loss after delivery of neonate
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From 0 to 24 hours after delivery of neonate
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Mode of delivery
기간: From full cervical dilation to delivery of neonate( within 4 hours)
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The final mode of delivery:
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From full cervical dilation to delivery of neonate( within 4 hours)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postpartum endometritis
기간: Time of delivery to discharge of mother( within 96 hours after delivery)
|
Diagnosed by the presence of at least two (2) of the following: 1. Fever (temperature greater than or equal 38 degrees celcius or 100.4 degree Fahrenheit; 2. Pain or uterine tenderness with no other recognized cause and 3. purulent drainge from the uterus. |
Time of delivery to discharge of mother( within 96 hours after delivery)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Valmiki Vijay Seeraj, MD, Bronxcare Healthcare System
- 연구 책임자: Emmanuel Afful, MD, MPH, Bronxcare Healthcare System
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
약물 및 장치 정보, 연구 문서
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