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Набор скоро начнётся NCT07653334

Effect of Maternal Awareness of the Duration fo the Second Stage of Labor on the Length of the Second Stage

Без фазы С лечением Labor, Second Stage Motivation Feedback, Psychological Self Efficacy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Time aware.
Кому может быть актуально
Состояния в реестре: Labor, Second Stage, Motivation, Feedback, Psychological, Self Efficacy. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Maternal Awareness of the Duration fo the Second Stage of Labor on the Length of the Second Stage: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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

1. 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. 2. 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. 3. Study Design A single-center, parallel-group, randomized controlled trial with a 1:1 allocation ratio. 4. Setting The trial will be conducted on the Labor and Delivery unit of Bronxcare, a community hospital with approximately 1500 births per year.

Вмешательства

  • Поведенческое Time aware
    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 relev

Первичные конечные точки

  • Mean difference of the duration of the second stage of labor [Срок оценки: 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 [Срок оценки: full cervical dilatation to expulsion of the fetus]
Вторичные конечные точки (9)
  • Maternal satisfaction and perceived control [Срок оценки: Within 48 hours postpartum]
  • Maternal self-report exhaustion [Срок оценки: within 24 hours postpartum]
  • Degree of perineal laceration. [Срок оценки: Within 10-minutes from the delivery of the placenta]
  • 5-minute APGAR score [Срок оценки: 5 minutes after delivery of neonate.]
  • Umbilical artery pH [Срок оценки: Sample collection: 0 to 5 minutes from resection of the umbilical cord. Analyzed within 60 minutes of collection.]
  • Neonatal Intensive Care Unit(NICU) admission [Срок оценки: From birth to 72 hour after delivery.]
  • Duration of NICU admission [Срок оценки: From birth to 7 days]
  • Quantifiable blood loss [Срок оценки: From 0 to 24 hours after delivery of neonate]
  • Mode of delivery [Срок оценки: From full cervical dilation to delivery of neonate( within 4 hours)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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. PMID 19461419
  • 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 PMID 19788967
  • 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 24901265

Идентификаторы

NCT: NCT07653334 · 04092601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗