Clinical Research Directory

Effect of Birth Dance on Birth Beliefs

This randomized controlled study was conducted to determine the effects of birth dance on birth beliefs, perceptions of supportive care needs, and anxiety levels in primiparous women. The study will be conducted with primiparous women in the experimental and control groups. The Birth Beliefs Scale, the Scale of Women's Perception for Supportive Care Given During Labor (SWPSCDL), and anxiety level assessments will be used to evaluate outcomes. The relationship between birth beliefs and anxiety levels will be examined.

The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique

This study aims to determine the 90% effective initial volume of 0.1% ropivacaine for labor analgesia under the double dural puncture epidural technique

Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique

This study aims to determine the 90% effective dose (ED₉₀) of an initial regimen of 0.1% ropivacaine combined with 0.3 μg/mL sufentanil, administered via the double dural puncture epidural technique for epidural labor analgesia.

Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor

Oxytocin is a key hormone that regulates uterine contractions during labor. Dural Puncture Epidural Analgesia (DPEA) is a modern technique for labor pain relief that provides faster onset and more reliable analgesia than standard epidural.While it is known that neuraxial analgesia can suppress oxytocin levels, it is unclear whether this effect depends on the stage of labor at which analgesia is administered. This prospective comparative study will enroll 120 pregnant women in spontaneous labor who request DPEA, divided into two groups: Early group (cervical dilation≤5 cm, n=60) and Late group (cervical dilation≥6 cm , n=60). Both groups receive identical DPEA (a total volume of 15 mL containing 0.1% bupivacaine and 100 µg fentanyl is administered through the epidural catheter, following dural puncture with a 26G spinal needle without intrathecal drug injection). The primary outcome is the percentage change in plasma oxytocin from baseline (T-0, before analgesia) to T-Eff (30 minutes after onset of effective analgesia defined as VAS\<2). Patients who received any exogenous oxytocin (induction or augmentation) before T-0 are excluded to ensure that the measured oxytocin represents endogenous production. The study will contribute to understanding how the timing of neuraxial analgesia relative to labor progression affects the endogenous oxytocin system, with potential implications for optimal clinical timing of labor analgesia administration.

Effect of Dance on Labor Pain in Primiparous Women

This randomized controlled trial evaluated the effect of labor dance on labor pain in primiparous women. Primiparous women admitted for vaginal birth to seven hospitals of a university affiliated private hospital group in Istanbul, Turkiye, were randomly assigned to a labor dance group or a routine care group. Women in the dance group danced to music of their choice at 30 minute intervals from 4 cm cervical dilatation until full dilatation, using movements intended to widen the pelvic diameters, in addition to routine intrapartum care. Labor pain was measured with a Visual Analogue Scale at 4 cm dilatation and repeatedly until full dilatation. Cervical dilatation and the duration of the active phase of labor were recorded.

Exploring the Effect of Aromatherapy

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

Stress Ball Intervention During Active Labor

This randomized controlled trial evaluates the effect of a stress ball intervention used during the active phase of labor primarily on maternal self-efficacy, while secondarily examining childbirth comfort, labor pain intensity, and labor progress. Labor pain is a multidimensional experience influenced by physiological and psychological factors, including coping and perceived control. Simple non-pharmacological interventions may support women's coping and active participation during labor. Participants in the intervention group use a stress ball during uterine contractions throughout the active phase of labor in addition to routine midwifery care, while participants in the control group receive routine midwifery care alone. Maternal self-efficacy and childbirth comfort are assessed at baseline during the active phase of labor and within 24 hours postpartum. Labor pain intensity is assessed using a Visual Analogue Scale at predefined cervical dilatation levels (5, 6, 8, and 10 cm). Labor progress parameters, including uterine contraction characteristics and fetal heart rate, are also monitored throughout the active phase. The primary objective is to determine whether stress ball use during active labor improves maternal self-efficacy. Secondary objectives are to evaluate its effects on childbirth comfort and labor pain intensity and to examine whether the intervention adversely affects physiological labor progress.

Pain Selective Anesthesia for Labor Mobility (PSALM Study): a Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine for Labor Epidural Analgesia

The current "gold standard" epidural analgesia for labor is associated with unwanted side effects, such as motor block (affecting ambulation and the ability to push) and sympathetic blockade (causing maternal hypotension). Here, using direct clinical application of preclinical findings, the investigator assess a novel method for prolonged pain-selective anesthesia during labor avoiding motor block, sympathetic block or other neural side effects. The approach is based on the pain-selective anesthesia the investigator developed in preclinical models, where the exclusive presence of TRPV1 channels on pain fibers (nociceptors) was exploited. The investigator used polarized, membrane-impermeable local anesthetics, together with the co-administration of direct TRPV1 agonists to open TRPV1 channels, so allowing these impermeable local anesthetics to gain selective access to nociceptors. Early preclinical studies used capsaicin as the TRPV1 agonist and QX-314 as the polarized local anesthetic, but neither of these drugs are appropriate for clinical use. Here the investigators use lidocaine as the TRPV1 activator and chloroprocaine as the polarized local anesthetic and hypothesize that this co-administration will elicit pain-selective (nociceptor-specific) anesthesia for labor without side effects. Positive findings in this study will be the first evidence in humans of pain-selective local anesthesia and will be the harbinger for future studies of systemic and regional administration of these drugs for pain-selective local anesthesia for chronic and other pain states.

Intracervical Balloon Placement With Nitrous Oxide Administration

This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor.

Using Wet Towel During Labor

The goal of this clinical trial is to learn whether the wet towel method applied during the first stage of labor can reduce labor pain and anxiety and improve childbirth comfort in first-time mothers. The main questions it aims to answer are: Does the wet towel method reduce labor pain? Does the wet towel method improve childbirth comfort? Does the wet towel method reduce anxiety during labor? Researchers will compare women who receive the wet towel method in addition to routine intrapartum care with women who receive routine intrapartum care alone to determine whether the intervention improves maternal outcomes during labor. Participants will: Be randomly assigned to either the wet towel intervention group or the routine care control group. Receive the wet towel application for at least 10 minutes during the active phase of the first stage of labor or receive routine intrapartum care only. Complete assessments of labor pain, childbirth comfort, and anxiety before and after the intervention using validated measurement tools

Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women

This study is designed to evaluate whether a virtual reality (VR) intervention can help reduce pain and anxiety and improve childbirth satisfaction among laboring women. Eligible participants will be randomly assigned to either a VR intervention group or a control group receiving standard intrapartum care. Women in the VR group will use a virtual reality headset that provides immersive natural imagery and music during labor, while women in the control group will receive routine care without VR. The study will compare levels of labor pain, anxiety, and childbirth satisfaction between the two groups to determine the effectiveness of the virtual reality intervention as supportive care during labor.

Epidural vs. Dural Puncture Epidural in Labor Analgesia

Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction

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

PurposeThis randomized controlled trial (RCT) aims to evaluate the effects of antenatal ThetaHealing meditation training on labor pain and childbirth fear among primiparous women.ObjectivesTo enhance childbirth satisfaction by enabling laboring women to utilize the ThetaHealing meditation technique during delivery.To assess the efficacy of ThetaHealing meditation in alleviating labor pain and fostering pain adaptation.To evaluate the impact of ThetaHealing meditation on reducing childbirth fear and enhancing psychological coping mechanisms during labor.To optimize intrapartum comfort via ThetaHealing meditation, thereby promoting spontaneous vaginal delivery.Background and HypothesesLabor pain and fear of childbirth (tokophobia) significantly influence maternal delivery preferences. Exposure to negative birth narratives often instills maladaptive beliefs, leading women to anticipate traumatic, high-risk birth outcomes. Implementing antenatal ThetaHealing meditation aims to cultivate positive cognitive reframing, thereby improving maternal comfort during labor.Furthermore, continuous midwifery support enhances maternal self-efficacy and emotional security, which directly impacts delivery outcomes. Although empirical literature regarding intrapartum electroencephalographic (EEG) activity remains limited, clinical observations suggest that routine hospital admissions-characterized by continuous electronic fetal monitoring (NST), bright lighting, and procedural interventions-predominantly induce beta-wave activity associated with heightened stress and anxiety. Transitioning to a low-stimulus environment with continuous midwifery care may facilitate a shift toward alpha brainwave activity ($8\\text{--}12\\text{ Hz}$), promoting relaxation. Under self-paced labor conditions, women may further transition into theta-wave activity ($4\\text{--}8\\text{ Hz}$), a state of heightened intuition, reduced distress, and somatic attunement.Given the lack of quantitative neurophysiological data during labor, this study utilizes EEG monitoring to track maternal brainwave frequencies during ThetaHealing meditation. By evaluating the method's efficacy in fostering alpha and theta frequencies, this research seeks to mitigate unnecessary cesarean deliveries, alleviate childbirth fear and pain, and address a key gap in the neuro-obstetric literature.Key Enhancements:Randomized controlled study $\\rightarrow$ Randomized controlled trial (RCT): Standard medical abbreviation.Childbirth fear $\\rightarrow$ Fear of childbirth (tokophobia): Incorporates accepted clinical terminology.Surrender $\\rightarrow$ Somatic attunement / Psychological coping: Replaced the non-clinical concept of "surrender" with precise biobehavioral language suitable for medical journals.Brain wave $\\rightarrow$ Brainwave frequency / EEG activity: Standard neurophysiological terms.

Early Labor Pre-Marking for Epidural Analgesia: Ultrasound vs Manual Palpation

The goal of this clinical trial is to learn if finding and marking the best spot on the back early in labor helps doctors perform epidural pain relief more successfully in pregnant women. Usually, epidural pain relief is requested when labor pain is already severe, which makes it hard for women to hold still. This makes it difficult to find the right needle spot, leading to more needle attempts The main questions this study aims to answer are: * Does using ultrasound to mark the back early in labor (before severe pain starts) help the doctor place the needle correctly on first try without adjusting it? * Does this early marking method lower the number of needle attempts and the time it takes to finish the procedure? Researchers will compare marking the back using an ultrasound machine to the standard method of feeling the spine with hands. Both methods will be done early in the waiting room to avoid the challenges caused by severe pain. Importantly, neither the pregnant women nor the doctors performing the epidural will know which marking method was used. This design prevents personal beliefs or expectations from affecting the procedure, making the study results objective and trustworthy. Participants will, if consented and participated in the study: * Have their lower back examined and marked by a doctor early in labor using either an ultrasound machine or the doctor's hands. * Receive an epidural pain relief in the delivery room when they request it. This will be done by a different doctor who does not know how the back was marked. * Answer short questions about their pain level and how happy they are with the procedure.

Yintang Acupressure During Labor in Primiparous Women

This randomized controlled study evaluated whether acupressure applied to the Yintang point during labor affects labor duration, pain, anxiety, and childbirth satisfaction in primiparous women. A total of 104 women were randomly assigned to either the Yintang acupressure group or the sham light-touch control group, with 52 participants in each group. Participants in the intervention group received five acupressure sessions during labor and the early postpartum period. Participants in the control group received routine midwifery care and light touch at a non-therapeutic forehead location. Labor duration, pain intensity, anxiety, and childbirth satisfaction were compared between the groups.

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.

Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.

Effects of the Rebozo Technique During Active Labor on Labor Pain and Labor Duration in Primiparous Women

Study Description Childbirth is a physiological process often accompanied by severe pain and prolonged labor, which may negatively affect maternal well-being and increase the likelihood of obstetric interventions. Non-pharmacological approaches that support physiological labor are recommended as part of evidence-based intrapartum care. The Rebozo technique is a traditional midwifery intervention involving rhythmic pelvic mobilization using a woven cloth to promote maternal comfort, facilitate fetal descent and rotation, and improve labor progression. This single-center, parallel-group randomized controlled trial aims to evaluate the effectiveness of the Rebozo technique on labor pain intensity and labor duration among primiparous women during the active phase of labor. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group, receiving the Rebozo technique in addition to routine intrapartum care, or the control group, receiving routine intrapartum care alone. The primary outcomes are labor pain intensity, assessed using the Visual Analog Scale (VAS), and labor duration, measured from the active phase of labor (6 cm cervical dilatation) until birth. The findings are expected to provide evidence regarding the effectiveness, feasibility, and clinical applicability of the Rebozo technique as a safe, low-cost, non-pharmacological intervention to support physiological childbirth and improve maternal intrapartum outcomes.

The Effect of Musıc on Labor Paın, Anxıety and Breastfeedıng Success

The aim of this study is to examine the effects of music played to primiparous women who had a cesarean section on pain, state anxiety and breastfeeding success.

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.

Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor.

Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique

DPEA (Dural Puncture Epidural Analgesia) is an alternative to the conventional epidural analgesia and technically a Combined Spinal Epidural (CSE) with omission of intrathecal drugs administration. To date, literature has proved several advantages of the DPEA techniquecompared to conventional epidural. However, these advantages are supposed to be limited to the use of 25 Gauge spinal needles. The aim of this project is to compare the quality of analgesia achieved after a DPEA technique performed with a 25 Gauge spinal needle versus a 27 Gauge spinal needle versus a conventional epidural, with a PIEB pump installed for analgesia maintenance. The Primary outcome will be the quality of analgesia, defined as the area under the curve (AUC) of the Numeric Pain Rating Scale (NPRS 100-0) ≤ 30 measured throughout labor and divided by labor duration (TWA-NPRS). 240 nulliparous women between the 36th and 42nd gestational week in active labor and with a cervical dilation ≤ 5 cm will be randomized according to a computer-generated random number sequence to receive a DPEA with a 25 Gauge spinal needle, a DPEA with a 27 Gauge spinal needle, or a conventional epidural.

Dural Puncture Epidural (DPE) Technique: Efficacy and Safety Overview.

Neuraxial techniques such as lumbar epidural and combined spinal-epidural (CSE) are the most effective methods for labor analgesia and are associated with high patient satisfaction. However, standard epidurals can have failure rates and may be difficult to reliably confirm correct placement. The dural puncture epidural (DPE) technique has been introduced to improve confirmation of epidural placement and potentially enhance analgesia. It involves identifying the epidural space, puncturing the dura with a spinal needle without injecting medication, confirming cerebrospinal fluid flow, and then placing the epidural catheter. While DPE may improve analgesia and drug spread, current evidence is limited and does not clearly demonstrate superiority over standard epidural techniques. At The Ohio State Wexner Medical Center, DPE is used routinely for labor epidurals. This observational study evaluates epidural failure rates and anesthesia provider confidence in performing DPE, while also collecting procedural details, patient characteristics, analgesic outcomes, and complications. Provider confidence is assessed using a 3-point scale along with factors influencing performance, and patient outcomes include pain relief, need for rescue dosing, and overall epidural effectiveness.

ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.