Clinical Research Directory

Storytelling for Provider Empathy & Patient Trust in Obstetric Care

Aim 3 is a provider-focused pilot randomized controlled trial evaluating a digital storytelling intervention to increase obstetric care providers' empathy and to examine associations with postpartum patient trust. Providers randomized to the intervention view a video of Black women's labor pain and care experiences and complete a brief reflection; control providers receive general culturally sensitive care materials. Outcomes include change in provider empathy (primary) and patient trust among Black postpartum patients under those providers' care (secondary). Risks are minimal and mitigated via consent, voluntary participation, the option to skip questions, and secure data practices.

Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery

This prospective observational cohort study aims to evaluate the association between postpartum recovery quality and mother-infant bonding in women undergoing vaginal delivery. Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire, and mother-infant bonding will be evaluated using the Postpartum Bonding Questionnaire (PBQ). Participants will be grouped according to routine clinical labor analgesia preference: women receiving labor epidural analgesia and women not receiving epidural analgesia. Additional assessments will include postpartum pain intensity, anxiety, depressive symptoms, and birth satisfaction. Baseline psychological assessments will be performed before delivery. The primary postpartum evaluation will be conducted between 6 and 24 hours after delivery. Exploratory follow-up assessments will be performed by telephone during postpartum week 2. The study aims to better understand the relationship between labor analgesia, postpartum recovery, and early mother-infant bonding outcomes after vaginal delivery.

Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida

The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes.

Determination of the Optimal "Next Bolus" Interval for Programmed Intermittent Bolus Epidural Analgesia

The current standard of practice for the maintenance of epidural analgesia is through use of a continuous infusion pump. Enhanced technology now supports the use of programmed intermittent bolus (PIEB) administration. This novel drug delivery system provides small boluses of local anesthetic and opioid at programmed intervals. Several studies suggest that administration of PIEB allows a more extensive spread of local anesthetic in the epidural space and provides superior labour analgesia compared to traditional continuous epidural infusions. PIEB is associated with lower anesthetic consumption, a shorter second stage of labour and greater patient satisfaction. The authors are focusing on a PIEB setting known as the "Next Bolus". "Next Bolus" (NB) determines when the first PIEB bolus is given after the initiation of the epidural and starting the PIEB pump. Currently we set this to be 15-45 minutes. In an attempt to optimize resources, authors hope to determine the optimal NB interval that will provide adequate analgesia but limit overall drug consumption. An optimally timed next bolus should minimize drug costs and limit nurse and physician intervention by decreasing the need for manual boluses.Increased local anesthetic consumption can cause undesirable side effects such as itchiness, decreased blood pressure and motor blockade. By assigning patients to receive the NB at 15, 30 or 45 minutes the authors hope to find the interval that provides analgesia while minimizing side effects, improving patient safety. If the bolus is given too late then there may be increased pain, less patient satisfaction, and the need for more analgesia in the form of Patient Controlled Epidural Anesthesia or a manual bolus.The authors hope that determining the NB will result in an institutional change to improve patient outcomes and facilitate knowledge transfer. This information will be the first available research to help guide other obstetrical centres using PIEB technology in determining the optimal NB interval.

Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction

This randomized controlled study aimed to evaluate the effect of continuous birth support provided by senior student midwives on labor outcomes, birth perception, and birth satisfaction. Pregnant women admitted for spontaneous vaginal birth were randomly assigned to either a continuous birth support group or a routine care control group. The intervention consisted of continuous non-pharmacological support provided by trained student midwives under supervision throughout labor. Primary outcomes included perceived birth pain and birth satisfaction, while secondary outcomes included birth perception and obstetric interventions.

Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Continuous Remote Vital Sign Monitoring During Labour Analgesia With Remifentanil

Continuous remote vital sign monitoring during labour analgesia with remifentanil - a prospective observational study Remifentanil PCA represents a well-tolerated, effective and valuable option for labour analgesia, yet its wider implementation is still limited by concerns of opioid side-effects particularly the risk of respiratory depression leading to desaturation, potentially affecting the foetus. Thus, continuous one-to-one observation and monitoring in the delivery room, with the midwife unable to leave the patient unattended, is recommended. Such constant one-to-one monitoring may be challenging in present health-care settings where staffing constraints may limit the implementation of remifentanil as routine obstetric care. Continuous remote vital sign monitoring to display oxygen saturation (SpO₂), respiratory rate, and heart rate on a handheld device (smartphone), has the potential to address this barrier by allowing the midwife to leave the labour room for short, predefined intervals while maintaining continuous surveillance of maternal vital signs. Such an approach could free staff resources without compromising patient safety. While centralised foetal monitoring (CTG) is standard practice in many units, the application of continuous remote vital sign monitoring for women receiving remifentanil during labour has, to our knowledge, never been formally studied. Objectives The aim is to study whether remote monitoring during remifentanil patient-controlled analgesia (PCA) for labour affects the incidence of maternal desaturation and other safety outcomes (bradypnoea, bradycardia, and neonatal outcomes, assessed via Apgar scores and umbilical cord pH.) The study will be conducted in a setting where remifentanil PCA is administered for labour analgesia and the midwife is permitted to leave the labour room for intervals of up to 10 minutes while the woman is remotely monitored using a handheld device carried by the midwife. Predefined criteria for when the woman must be accompanied (e.g., if SpO₂ \< 94%, supplemental oxygen \>2L/min., or decreased consciousness). Outcomes in this group will be compared with a control group where the midwife remains continuously present in the labour room.

Effectiveness of Sacral Massage on Labor Pain, Depression, Stress, and Anxiety

to identify the effectiveness of sacral massage on labor pain, depression, stress, and anxiety: A randomized clinical trial

Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural

Neuraxial analgesia has shown to be the gold standard for effective labor pain relief, offering numerous benefits including enhanced pain control and maternal satisfaction. The methods to achieve neuraxial analgesia include lumbar epidural (LE), and combined spinal epidural (CSE). While LE may not consistently provide optimal pain relief, leading to frequent maternal requests for supplemental analgesics, CSE presents a promising advancement. This is due to the rapid onset of pain relief from intrathecal components, complemented by the longer-lasting effects of epidural medications. Intrathecal drugs have demonstrated the ability to offer more symmetrical blockades compared to epidurally administered medications. Nonetheless, some clinicians remain cautious about CSE due to the potential for increased pain when transitioning from spinal to less effective epidural analgesia. Long-acting opioids like morphine in the intrathecal space may mitigate this problem by providing transitional analgesia to the laboring parturient. The primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal (spinal) component of CSE reduces the rate of breakthrough pain during labor.

Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS)

This study aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) for pain management during labor induction by cervical ripening. Labor induction is a common obstetric procedure and cervical ripening may be associated with painful uterine contractions. Non-pharmacological analgesic methods such as TENS could help improve pain management during this phase. However, evidence regarding its effectiveness in this context remains limited. This randomized, controlled, open-label monocentric study will compare the use of TENS in addition to usual analgesic care versus usual analgesic care alone in pregnant women undergoing labor induction with cervical ripening. The primary objective is to assess whether TENS reduces the need for neuraxial analgesia or delays its use during labor.

The Stimulation To Induce Mothers Study

The investigators propose a parallel group randomized clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The central hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery, improves patient-centered outcomes such as childbirth satisfaction, labor agentry, and pain scores, and reduces adverse neonatal and maternal outcomes in nulliparous women. The investigators will pursue the following specific aims: 1) Assess the effectiveness of intrapartum nipple stimulation on the rate of spontaneous vaginal delivery in nulliparous women, 2) Breastfeeding as the sole source of nutrition at time of maternal hospital discharge (Primary Aims); 3) Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life, 4) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes, 5) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes and 6) In a sub-cohort of women who are enrolled in the trial, investigators will measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern.

Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor

This randomized, double-blind, placebo-controlled trial aims to compare the analgesic efficacy and obstetric effects of tramadol (100 mg IV) versus paracetamol (1 g IV) versus placebo (saline solution) in nulliparous women during active labor. The primary outcome is duration of active labor (minutes). Secondary outcomes include duration of expulsive phase, type of delivery, need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension), and neonatal outcomes (Apgar scores at 1 and 5 minutes, NICU admission). The study hypothesizes that tramadol significantly reduces active labor duration compared to paracetamol and placebo, without compromising maternal or neonatal safety. A total of 300 nulliparous women (100 per group) will be enrolled at Hospital Escuela, Tegucigalpa, Honduras.

Left Lateral Position vs Supine Position to Reduce Active Labor Duration

This randomized clinical trial aims to compare the effect of the left lateral decubitus position versus the supine position on the duration of the active phase of labor in nulliparous women. A total of 188 participants will be randomly assigned to one of two groups. The intervention group will be placed in the left lateral decubitus position, while the control group will remain in the supine position. Both positions will be maintained for 30-minute intervals with 5-minute rest periods, continuing until delivery. The primary outcome is the duration of the active phase of labor. Secondary outcomes include rates of cesarean section, use of oxytocin and analgesics, and maternal and neonatal complications.

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.

This is a randomized, double-blind, crossover clinical trial to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapeutic intervention for reducing pain in women during the active phase of labor. Nulliparous women with term pregnancies will be randomly assigned to sequences involving TENS intervention and placebo (device off) periods, separated by a washout. The primary outcome is labor pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include duration of the active labor phase, maternal and neonatal safety profile, and childbirth experience satisfaction. The study will be conducted at the Hospital Escuela Universitario from feb 2026 to Ago 2026.

Comparing PIEB and CEI for Labor Pain Relief

The purpose of this randomized controlled trial is to compare the efficacy and safety of two epidural analgesia maintenance methods for labor pain relief: Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI), both combined with Patient-Controlled Epidural Analgesia (PCEA). The study aims to evaluate which technique provides superior analgesia while minimizing anesthetic consumption and preserving maternal motor function. A total of 60 parturients at Family Hospital, Da Nang, will be randomly assigned to either the PIEB or CEI group. Outcomes including pain intensity (VAS scores), total drug consumption, maternal satisfaction, and neonatal Apgar scores will be assessed.

Sacral Pressure During Labor: Effects on Pain and Maternal Satisfaction

The study will be conducted with pregnant women in the active and transitional phases of labor. In the intervention group, sacral pressure will be applied during contractions, while the control group will receive routine clinical care. Perceived labor pain and maternal satisfaction will be assessed throughout the labor process

Exploring the Effect of Aromatherapy

To explore the effect of aromatherapy in laboring patients with pain, anxiety, and/or nausea/vomiting.

Determining the Effect of the ThetaHealing Meditation Method Given During the Antenatal Period on Labor Pain and Fear in Primiparous Women

Purpose: This randomized controlled study was designed to determine the effect of the ThetaHealing meditation method given to primiparous pregnant women during the antenatal period on labor pain and fear. Objectives: 1. To increase childbirth satisfaction by enabling pregnant women to use the ThetaHealing meditation method during labor. 2. To ensure the use of the ThetaHealing meditation method during labor in order to reduce labor pain and/or facilitate adaptation to pain. 3. To reduce childbirth fear and/or facilitate adaptation to childbirth fear during labor by using the ThetaHealing meditation method. 4. To improve childbirth comfort through the ThetaHealing meditation method and thereby encourage vaginal birth. 5. Labor pain and childbirth fear are important factors that affect pregnant women's birth preferences. Negative birth experiences heard from women's social environment create beliefs that their own births will also be difficult, bloody, and traumatic. 6. Teaching the ThetaHealing meditation method to pregnant women during the antenatal period and enabling them to use their minds positively during labor is thought to increase women's comfort at the time of birth. In addition, continuous midwifery care during labor is known to increase a woman's self-confidence. A woman's feeling well and safe will influence the mode of birth. There is no research in the literature specifically addressing brain waves and childbirth. However, based on information conveyed by healthcare professionals, it is thought that after the procedural processes that begin when a woman is admitted to the hospital for birth, pregnant women remain in the beta frequency together with stress and anxiety. This is because the beta frequency is a brain wave in which surrender cannot be achieved and the person experiences intense stress and anxiety. It is clear that a woman cannot reach a state of surrender while feeling anxiety and worry under bright hospital lights in a room filled with NST sounds. With the progression of labor, a calmer environment, dim lighting, and continuous midwifery support, it is thought that the pregnant woman can reach the alpha brain wave and become ready for surrender.It is even thought that if the progression of labor is left to the woman's control, she may reach the theta brain wave. A woman who can reach the alpha or theta brain wave is awake but in a continuous sleep-like state. She is now away from anxiety and stress, intuitive, instinctive, and attuned to the labor process. Since there is no scientific study on the effect of brain frequencies on the labor process, brain wave activity during labor has been inferred based on midwives' observations. By providing education on the ThetaHealing meditation method to pregnant women in the antenatal period, it is aimed to help women attune to the alpha and/or theta frequency, thereby reducing the increase in cesarean rates and facilitating adaptation to childbirth fear and pain. For these purposes, an EEG device is needed to determine in which frequency range the brain waves are during labor when the ThetaHealing meditation method is used. By investigating the effectiveness of the training using an EEG device, a contribution will be made to the literature.

Effect of Multi-Sensory Interventions on Labor Pain, Comfort, and Birth Satisfaction

The goal of this clinical trial is to learn whether different multi-sensory methods can help lower labor pain and improve comfort and birth satisfaction among pregnant women giving birth vaginally. The main questions this study aims to answer are: Do supportive methods such as massage, lavender aromatherapy, Turkish makam music, or aquarium visual stimulation help women feel less labor pain compared to standard care? Do these methods increase women's comfort and satisfaction during labor? Participants will be randomly assigned to one of five groups: Sacral massage group - will receive 10-minute sacral massages three times during labor. Lavender aromatherapy group - will inhale lavender essential oil through a diffuser for 20 minutes, three times during labor. Music therapy group - will listen to Turkish makam music (Rehavi or Nihavend) for 20 minutes, three times during labor. Visual stimulation group - will watch a live aquarium image continuously during active labor. Control group - will receive standard maternity care only. All participants will give informed consent and receive care in the obstetrics unit of Kütahya City Hospital, Türkiye. Researchers will measure: Labor pain intensity at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation using a Visual Analogue Scale (VAS). Comfort level at 8-9 cm using the Comfort Characteristics Questionnaire (CCQ). Birth satisfaction about 2 hours after delivery using the Birth Satisfaction Scale (BSS). Labor duration will also be recorded. This study will help determine which sensory methods are most effective and comfortable for pregnant women, and may guide supportive care practices during childbirth.

Virtual Reality for Pain and Anxiety Relief in Labor

The aim of this study is to evaluate the impact of virtual reality hypnosis technique on pain and anxiety of women during labor. We will perform a randomized controlled trial on a group of labouring women at several hospitals in Tunis. We will also evaluate the satisfaction of women after the exposure to the virtual reality headset.

Music Therapy for Labor Pain and Anxiety

This multicenter randomized controlled trial evaluates the effectiveness of music therapy in reducing pain and anxiety during the latent and active phases of labor in Tunisian women. Participants are randomized to receive either music therapy or standard care. Primary outcomes are pain (VAS) and anxiety (STAI-Y). Secondary outcomes include labor duration, maternal and fetal vital signs, neonatal outcomes, and maternal satisfaction.

Neuraxial Labor Analgesia and Offspring Neurodevelopment

How perinatal factors affect the long-term development of children has always been an issue of much concern. This study is designed to explore the potential impact of maternal neuraxial labor analgesia exposure on offspring neurodevelopment.

Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)

Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block. Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships. The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.

The Effect of Foot Reflexology Massage on the Perception of Labor Pain in Nulliparous Pregnant Women

To evaluate the effect of reflexology massage, which is a non-pharmacological tool based on the effect of reflexology massage applied to the foot, on the perception of labor pain, on the perception of labor pain.