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Trial of Ultrasound-guided Rotation for Normalizing Head Position

Intrapartum Ultrasound-Guided Early Manual Rotation for Correcting Abnormal Fetal Head Position: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07781189
Acronym
TURN-HEAD Tria
Enrollment
164
Registered
2026-08-24
Start date
2026-08-01
Completion date
2028-03-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Fetal Head Position

Keywords

Intrapartum Ultrasound-Guided, Manual Rotation, Correcting Abnormal Fetal Head Position, Randomized Controlled Trial

Brief summary

Intrapartum Ultrasound-Guided Early Manual Rotation for Correcting Abnormal Fetal Head Position The goal of this clinical trial is to learn whether using ultrasound during labor, followed by early manual rotation of the baby's head when needed, can help more women give birth vaginally when the baby's head is facing an unfavorable direction. During labor, most babies turn so the back of the head faces the front of the mother's pelvis. This position usually makes birth easier. Some babies remain in a back-facing or side-facing position, called occiput posterior or occiput transverse position. These positions may make labor longer and may raise the chance of assisted vaginal birth or cesarean birth. In this study, trained midwives or obstetric clinicians will use intrapartum ultrasound, which is an ultrasound scan during labor, to check the baby's head position. Ultrasound is non-invasive and can give a clearer and more objective picture than examination by touch alone. If the baby's head is in an unfavorable position and the participant meets the study safety criteria, the clinician may try manual rotation. Manual rotation means using the hand to gently help turn the baby's head into a more favorable front-facing position. Researchers will compare two groups. One group will receive ultrasound-guided early manual rotation when the cervix is about 5 to 7 centimeters open and the baby's head is low enough. The other group will receive usual labor care, including standard examinations and usual clinical management. Participants will be assigned to one of these groups by chance, like flipping a coin. The main question is: Does ultrasound-guided early manual rotation increase the chance of vaginal birth? The study will also learn about safety and other birth outcomes, including whether the baby's head turns successfully, how long labor lasts, whether forceps or cesarean birth is needed, bleeding after birth, fever or possible infection, perineal injury, the mother's birth experience, breastfeeding, and newborn outcomes such as Apgar score, umbilical cord blood pH, need for resuscitation, birth injury, or admission to the neonatal intensive care unit. Participants will: * Have eligibility checked during labor. * Have an ultrasound scan to check the baby's head position. * Be randomly assigned to one of the study groups if they meet the study criteria. * Continue to receive close labor monitoring, including fetal heart rate monitoring. * Have birth and newborn information collected from medical records. * Complete follow-up after birth, including up to 42 days after delivery. Possible benefits include a better chance that the baby's head turns to a favorable position, a higher chance of vaginal birth, and fewer complications related to prolonged or difficult labor. These benefits are not guaranteed. Possible risks include discomfort or pain during manual rotation, failed rotation, temporary fetal heart rate changes, vaginal or cervical injury, bleeding, or the need for urgent clinical care, including cesarean birth. The study team will stop the procedure and provide standard care if there are safety concerns. Taking part is voluntary. A participant may choose not to join or may leave the study at any time. This will not affect the usual care provided to the mother or baby.

Interventions

PROCEDURETrial of Ultrasound-guided Rotation for Normalizing Head position

This project introduces intrapartum ultrasonography combined with the manual cephalic rotation procedure. Midwives use intrapartum ultrasonography for early detection of abnormal fetal occiput positions . When cervical dilation reaches approximately 6 cm and the fetal presenting part is 1-1.5 cm below the ischial spine, manual cephalic rotation is performed to shift the fetal head to the occiput anterior position, allowing delivery through the maternal pelvis along the smallest cranial diameter (suboccipitobregmatic diameter). Observed maternal outcome indicators include the success rate of manual cephalic rotation, vaginal delivery rate, forceps delivery rate, conversion-to-cesarean delivery rate, duration of labor, episiotomy rate, severe perineal laceration rate and incidence of perineal hematoma; neonatal indicators cover the incidence of infants with 1-minute Apgar score ≤7, umbilical artery blood gas parameters and neonatal birth trauma rate.

PROCEDUREStandard Care plus Sham Ultrasound

Arm Description: All participants receive routine intrapartum management in our hospital. Interventions for the control group are as follows: a) Fetal position and labor progress are assessed via routine vaginal examination. b) Labor surveillance, labor analgesia and oxytocin titration are administered according to clinical indications. c) Sham ultrasound examination A newly purchased intrapartum ultrasound machine is used for sham ultrasound assessment. Only basic assessments including cephalic presentation confirmation and amniotic fluid volume measurement are performed; evaluation of fetal occiput position and other relevant parameters is omitted to avoid contamination between subjects allocated to different groups within the same ward. d) Given the difficulty in accurate fetal position diagnosis during the first stage of labor, manual fetal head rotation is performed once abnormal fetal position is identified by midwives, typica

Sponsors

Anhui Provincial Hospital
Lead SponsorOTHER_GOV
The First Affiliated Hospital, University of Science and Technology of China
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

This is a prospective, randomized, controlled, parallel-group clinical trial conducted in the delivery room of The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital). The study subjects are full-term, singleton, cephalic pregnant women planning vaginal delivery with intrapartum ultrasound confirming occiput posterior (OP) or occiput transverse (OT) position. Subjects will be randomized at a 1:1 ratio into an intervention group (intrapartum ultrasound combined with early manual fetal head rotation) or a control group (routine obstetric management plus sham ultrasound) via a central randomization system or computer-generated random sequence. Complete randomization is applied, and allocation concealment is achieved using an electronic randomization system or opaque sealed envelopes. A double-blind design is adopted in this trial. Parturients, outcome assessors and statistical analysts are kept blinded to group allocation throughout the s

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Singleton pregnancy, cephalic presentation and term gestation (37⁺⁰ to 41⁺⁶ gestational weeks) 2. Active phase onset at approximately 6 cm cervical dilatation (range defined as 5-7 cm) 3. Either intact or ruptured fetal membranes, with feasibility for intrapartum ultrasonographic assessment 4. Intrapartum ultrasound confirms persistent or definite abnormal fetal occiput position: occiput posterior (OP) or occiput transverse (OT) 5. Manual rotation of fetal head may be considered when cervical dilatation reaches about 6 cm and intrapartum ultrasound demonstrates fetal presenting part below the level of maternal ischial spines (with standardized clinical operator position and corresponding ultrasonic indicators) 6. No contraindications to vaginal delivery; g) Informed consent obtained and signed by the parturient.

Exclusion criteria

7. Non-cephalic presentation, brow presentation or face presentation 8. Suspected significant cephalopelvic disproportion 9. Conditions requiring urgent termination of pregnancy including placenta previa, placental abruption, umbilical cord prolapse and fetal distress 10. Previous scarred uterus unsuitable for trial of vaginal delivery;e) Multiple gestation;f) Major fetal structural anomalies or confirmed fetal chromosomal abnormalities 11. Intrauterine infection, maternal fever or other conditions deemed inappropriate for enrollment by researchers 12. Maternal voluntary refusal of manual fetal head rotation due to fear of labor pain or poor cooperation

Design outcomes

Primary

MeasureTime frameDescription
Vaginal Delivery RateThis indicator is documented immediately upon completion of childbirth and extracted by researchers from delivery recordsThe proportion of study subjects who complete delivery via the vaginal route, encompassing spontaneous vaginal delivery, forceps-assisted delivery, vacuum extraction and other vaginal delivery modalities. This indicator is documented immediately upon completion of childbirth and extracted by researchers from delivery records, inpatient medical histories and delivery room registration forms. A case is classified as vaginal delivery if the fetus is ultimately delivered vaginally; conversion to cesarean section during labor is categorized as non-vaginal delivery. Calculation formula for vaginal delivery rate: (Number of vaginal delivery cases ÷ total number of analyzed cases in the group) × 100%

Secondary

MeasureTime frameDescription
Number of participants with successful fetal position correctionImmediately after completion of intervention, upon entry into the second stage of labor, and at fetal deliveryNumber of participants with successful fetal position correction assessed by vaginal examination Revised fetal position refers to fetal cephalic position converted from abnormal presentations (occiput posterior position, occiput transverse position) to delivery-favorable positions including occiput anterior position, left occiput anterior position, or right occiput anterior position following clinical intervention.Fetal position is assessed via vaginal examination performed by uniformly trained obstetricians or midwives.Successful correction is defined as fetal occiput rotating to occiput anterior, left occiput anterior, or right occiput anterior after intervention. Correction is considered unsuccessful if the fetus remains in occiput posterior, occiput transverse, or other unfavorable fetal positions.
Success Rate of Manual Fetal Head RotationThis indicator is recorded immediately after the completion of the procedure, and the final fetal position is reconfirmed at fetal delivery.The success rate of manual fetal head rotation refers to the proportion of cases in which the fetal position is successfully converted to a position conducive to vaginal delivery following manual rotation of the fetal head. The attending obstetrician performing the operation documents the pre-procedural fetal position, post-procedural fetal position, procedural outcome, requirement for repeat rotation, and occurrence of related adverse events. The maneuver is defined as successful if the fetal head is rotated from occiput posterior or occiput transverse position to occiput anterior position without immediate reversion to an abnormal position during subsequent labor. It is classified as a failed attempt when positional rotation cannot be achieved, the fetal position reverts rapidly after manipulation, or
Intrapartum FeverRoutine maternal temperature monitoring commences at labour onset, with an inspection interval of 2 to 4 hours; monitoring continues until 24 hours after childbirth.Intrapartum fever is defined as elevated maternal body temperature occurring from the onset of labor to fetal delivery. The same temperature measurement method (axillary, tympanic or oral thermometry) is adopted throughout the study; the maximum body temperature and its onset time are documented accordingly. Intrapartum fever is defined as an intrapartum temperature ≥38.0 °C. Suspected chorioamnionitis/intrauterine infection refers to clinical manifestations suggestive of intrauterine infection emerging during labor. This outcome is comprehensively assessed by the attending physician based on maternal body temperature, fetal heart rate, maternal heart rate, uterine tenderness, amniotic fluid characteristic
Mode of DeliveryIt is abstracted from delivery records and operative notes immediately after childbirth completionMode of delivery is defined as the definitive delivery modality of parturients, which is abstracted from delivery records and operative notes immediately after childbirth completion, and categorized into spontaneous vaginal delivery, cesarean section and forceps-assisted vaginal delivery. Final fetal position at delivery refers to the fetal cephalic position upon fetal expulsion, determined by birth attendants according to the direction of fetal head delivery, occipital bone location and delivery documentation, and documented as occiput anterior, occiput posterior or occiput transverse position.
Forceps DeliveryRight after childbirthForceps delivery is defined as instrumental extraction with obstetric forceps performed for indicated clinical reasons during labor. This variable is abstracted from delivery records and forceps procedure documentation; cases with documented forceps application are coded as "Yes", whereas those without forceps use are coded as "No".
2-hour Postpartum Blood LossFrom fetal delivery to 2 hours after childbirthTwo-hour postpartum blood loss is defined as the total volume of vaginal bleeding from fetal delivery to 2 hours after childbirth. This indicator is quantified by quantitative measurement approaches, including blood collection bag collection, gravimetric method and dressing weight conversion method.
Total Duration of LaborFrom the onset of childbirth to immediate postpartum completion, assessed at deliveryTotal duration of labor is defined as the total time elapsed from the onset of regular uterine contractions to fetal delivery. It is calculated by extracting the initiation time of regular contractions, time of complete cervical dilatation and fetal delivery time from partograms, nursing records and inpatient medical records, with the unit of hours.
EpisiotomyImmediately after childbirth (at delivery)Episiotomy refers to surgical perineal incision performed for clinical indications during vaginal delivery. Data are abstracted from delivery records and documented as "Yes/No"; when applicable, the incision type is further specified as left mediolateral, right mediolateral or midline episiotomy.
The rate of Severe perineal lacerationimmediately after deliverySevere perineal laceration is defined as third- or fourth-degree perineal tear involving the anal sphincter or rectal mucosa. Following fetal delivery and prior to perineal repair, obstetricians conduct physical examination of the perineum, vagina and anal sphincter; digital rectal examination is performed when needed to confirm the extent of injury.The rate is defined as the count of severe perineal laceration cases divided by the total number of vaginal deliveries, then multiplied by 100%.
Perineal HematomaWithin 24 hours after deliveryPerineal hematoma is localized blood collection within the vulva, vagina or perineum after delivery, diagnosed by midwives or physicians based on inspection, palpation and maternal clinical manifestations, with ultrasonography arranged for confirmation as required. A case is marked "Yes" if localized swelling, pain, tenderness or violaceous mass is present with a confirmed clinical diagnosis of perineal or vaginal hematoma; the maximum diameter of hematoma (in cm) is recommended to be documented additionally.
Postpartum FeverDaily assessments, starting immediately after delivery (Day 0), through hospital discharge (1-day postpartum for vaginal delivery, 3-day postpartum for cesarean section)Postpartum fever is defined as elevated maternal body temperature occurring after fetal delivery.The maximum body temperature and its onset time are documented. Postpartum fever is preliminarily defined as body temperature ≥38.0 °C. To eliminate interference from transient physiological temperature fluctuations shortly after childbirth, an alternative diagnostic criterion can be adopted: temperature ≥38.0 °C beyond 24 hours postpartum, or two consecutive temperature readings ≥38.0 °C.
Amniotic Fluid CharacteristicsData is extracted from delivery records immediately postpartum.Amniotic fluid characteristics include color, clarity and odor of amniotic fluid, as well as the presence of meconium or blood, which are assessed and documented by midwives or delivery clinicians through gross visual examination after fetal delivery. The findings are categorized as clear, grade Ⅰ staining, grade Ⅱ staining and grade Ⅲ staining.
Proportion of Participants with Abnormal Umbilical Cord ConditionsImmediately postpartumMultiple umbilical cord abnormalities (nuchal cord, umbilical cord torsion, true umbilical knot, short umbilical cord) are clinically assessed and documented by birth attendants at delivery. All abnormal findings are aggregated to report the overall proportion of participants with abnormal umbilical cord conditions.
Number of participants with incomplete delivered placentaWithin 30 minutes following the expulsion of the delivered placentaAfter expulsion of the placenta, midwives or obstetric clinicians inspect the maternal surface, fetal surface, fetal membranes and umbilical cord insertion site. The judgement of incomplete placenta is completed by clinical macroscopic examination
Birth Weight of NeonatesData is extracted from delivery records immediately postpartum.Neonatal birth weight is defined as the nude body weight measured for the first time after delivery. Weight measurement is completed within 1 hour postpartum using a calibrated electronic infant scale after removing clothes, diapers and other accessories, recorded in grams with an accuracy of 10 g. Macrosomia is diagnosed based on birth weight; infants with birth weight ≥4000 g are classified as macrosomic infants.
1-minute and 5-minute Neonatal Apgar Scores1 and 5 minutes after birthThe 1-minute and 5-minute Apgar scores represent comprehensive assessments of neonatal heart rate, respiration, muscle tone, reflex irritability and skin color performed at 1 and 5 minutes after birth, respectively. Each item is scored from 0 to 2 points, yielding a total score ranging from 0 to 10. Scores are evaluated and documented by birth attendants or neonatologists in accordance with standardized Apgar scoring criteria.
Umbilical Arterial Blood Gas pH of NeonatesWithin 15 to 30 minutes after birthNeonatal umbilical arterial blood gas pH refers to the pH value obtained from blood gas analysis of umbilical arterial blood sampled after fetal delivery, which is used to assess the neonatal acid-base status at birth. The umbilical cord is double-clamped as soon as possible following delivery; blood specimens are collected from the umbilical artery and submitted for detection by a blood gas analyzer within 15 to 30 minutes after birth.
Neonatal ResuscitationData is extracted from delivery records immediately postpartum.Neonatal resuscitation is defined as any resuscitative intervention administered after birth due to abnormalities in respiration, heart rate, muscle tone or other conditions. This variable is abstracted from neonatal resuscitation records, covering initial stabilization, airway suctioning, bag-mask ventilation, endotracheal intubation, chest compressions, and epinephrine administration.
Caput Succedaneum AreaImmediately after birthCaput succedaneum area denotes the scope of scalp soft tissue edema forming caput succedaneum in newborns after delivery. Immediately after birth, trained research personnel measure the maximum longitudinal diameter and the perpendicular maximum transverse diameter of the lesion with a flexible measuring tape. A simplified area calculation formula is applied: Caput succedaneum area = maximum longitudinal diameter × maximum transverse diameter, with the unit of cm².
Occipitofrontal Circumference (Head Circumference)within 24 hours after birthNeonatal head circumference is defined as the maximal cranial perimeter. Measurement is completed within 24 hours after birth using an inelastic flexible tape wrapped around the skull through the superior margin of the supraorbital ridges and the most prominent point of the occipital protuberance, with centimeters as the measuring unit. Repeat measurement is recommended after resolution when obvious caput succedaneum or cranial molding exists.
Abdominal CircumferenceData is extracted from delivery records immediately postpartum.Neonatal abdominal circumference refers to the maximum abdominal perimeter. With the newborn in supine position and resting quietly, measurement is performed using an inelastic flexible tape encircling the abdomen at the umbilical level, recorded in centimeters (cm).
Neonatal Birth LengthWithin 24 hours after birthBirth length is the crown-heel length measured with the newborn in supine position. Measurement is finished within 24 hours after birth using an infant length board by two examiners. The infant's head is fixed and lower extremities fully extended to measure the distance from the top of the head to the heel, with centimeters (cm) as the unit.
Postpartum childbirth experienceThis indicator is assessed via qualitative interviews within 24-72 hours after delivery or prior to hospital discharge.Postpartum childbirth experience refers to the parturient's subjective perception of the labor process, including sense of safety, pain control, participation in decision-making, healthcare provider support, perceived control over childbirth and overall satisfaction. This indicator is assessed via qualitative interviews within 24-72 hours after delivery or prior to hospital discharge.A five-category Likert scale is adopted for satisfaction rating, consisting of five grades: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied.
Length of Hospital StayLength of hospital stay is defined as the total number of calendar days from the date of hospital admission to the date of hospital discharge for the index delivery, calculated as discharge date minus admission date(≤42 days after delivery).Length of hospital stay is defined as the total duration from maternal admission to hospital discharge. It is calculated post-discharge based on admission and discharge dates recorded in the hospital information system, with days as the unit.
Hospitalization CostsHospitalization costs refer to all medical expenses incurred during the index delivery hospitalization from admission to discharge, covering all items charged by the hospital for maternal inpatient care related to childbirth(≤42 days after delivery).Hospitalization costs refer to the total medical expenses incurred by the parturient during the current delivery-related hospitalization. After final billing upon discharge, researchers extract relevant data from the hospital charging system or front sheet of medical records, denominated in Chinese Yuan (CNY). According to research requirements, total costs can be further categorized into total hospitalization expense, out-of-pocket expense, pharmaceutical cost, examination fee, and surgical procedural cost.
Postpartum Blood Loss within 24 HoursFrom fetal delivery to 24 hours postpartumPostpartum blood loss within 24 hours is defined as the total vaginal blood loss from fetal delivery to 24 hours postpartum. Data are documented via a combination of blood collection pouch measurement, gravimetric method, nursing records and clinical estimation, with priority given to objective quantitative measurement; the unit is milliliters (mL). Postpartum hemorrhage is diagnosed when cumulative blood loss reaches ≥500 mL within 24 hours after vaginal delivery or ≥1000 mL following cesarean delivery.
Postpartum White Blood Cell (WBC) Count24-48 hours postpartumPostpartum WBC count refers to the white blood cell count in peripheral blood. Venous blood samples are collected 24-48 hours postpartum and tested via routine complete blood count in the hospital clinical laboratory, with the unit of ×10⁹/L. Repeat testing can be arranged when clinical infection is suspected.
Postpartum Hemoglobin24-48 hours postpartumPostpartum hemoglobin denotes the hemoglobin concentration in peripheral blood. Venous blood sampling for routine complete blood count is recommended within 24-48 hours postpartum, measured in g/L. This indicator is recorded as a continuous variable.
Perineal EdemaAt Day 1 after neonatal birth, Day 2 after neonatal birth and within 72 hours after neonatal birth before hospital discharge assessmentPerineal edema is characterized by swelling, tension, pain or localized tenderness of perineal tissues following delivery. Assessment via visual inspection and palpation by midwives or physicians is recommended at 24 hours postpartum, 48 hours postpartum and prior to hospital discharge.
Breastfeeding StatusAt Day 1 after neonatal birth and within 72 hours after neonatal birthBreastfeeding status reflects the feeding mode of neonates during maternal hospitalization. Relevant data are collected from nursing records and maternal interviews at 24 hours postpartum and before discharge, which are classified into exclusive breastfeeding, mixed feeding, formula feeding and mother-infant separation.
NICU TransferNICU transfer is defined as any transfer of the live newborn to the neonatal intensive care unit for specialized monitoring or therapeutic intervention within the initial postpartum hospitalization(≤42 days after delivery).NICU transfer refers to the admission of a newborn to the neonatal intensive care unit due to clinical necessity after birth. Relevant data are extracted from neonatal medical records, transfer documents and NICU admission records from birth until discharge; cases with documented NICU admission or transfer are coded as "Yes".
Birth Trauma in NeonatesStarting from the day of delivery until 42 days after birth.Neonatal birth trauma is defined as injuries occurring during delivery related to mechanical compression, obstetric manipulation or birth canal squeezing. Physical examination is performed by neonatologists from immediately after birth to pre-discharge, with supplementary imaging examinations conducted when necessary. Cases diagnosed by neonatologists with cephalohematoma, clavicular fracture, brachial plexus injury, facial nerve injury, intracranial hemorrhage, skin laceration or soft tissue injury are documented as neonatal birth trauma.
Neonatal ComplicationsStarting from the day of delivery until 42 days after birth.Neonatal complications refer to neonatal diseases or abnormal conditions requiring clinical evaluation or treatment occurring during postnatal hospitalization. Data are extracted from neonatal progress notes, medical orders, laboratory and imaging results as well as discharge diagnoses. Common complications consist of neonatal asphyxia, respiratory distress, hypoglycemia, hyperbilirubinemia, confirmed or suspected infection, feeding intolerance, meconium aspiration syndrome and acidosis.
Mechanical Ventilation SupportStarting from the day of delivery until 42 days after birth.Mechanical ventilation is defined as ventilatory support administered to neonates for respiratory insufficiency after birth. Relevant information is extracted from neonatal resuscitation records, NICU medical documents and physician orders from birth to hospital discharge. Infants receiving either non-invasive or invasive mechanical ventilation are marked as "Yes". Further classification into CPAP, non-invasive positive pressure ventilation and invasive endotracheal mechanical ventilation is recommended.
Neonatal Length of Hospital StayAt neonatal dischargeNeonatal length of hospital stay is defined as the hospitalization duration from neonatal birth/admission to discharge, which is calculated based on the infant's admission and discharge dates and recorded in days.
Neonatal Hospitalization ExpensesNeonatal hospitalization costs refer to all medical expenses incurred for live newborns during the index delivery hospitalization or any neonatal readmission within 42 days postpartum.Neonatal hospitalization expenses refer to the total medical costs incurred during the current admission. Data are collected from the hospital billing system or hospital settlement list after discharge billing, measured in Chinese Yuan (CNY).
Puerperal InfectionFrom discharge to 42 days postpartumPuerperal infection refers to genital tract or systemic infection occurring during the puerperium, including endometritis, wound infection, urinary tract infection, mastitis and other delivery-related infectious diseases. Data are collected via outpatient follow-up, telephone interview and electronic medical record review from discharge to 42 days postpartum. Researchers make comprehensive judgments based on maternal complaints, body temperature, clinical diagnosis, antibiotic administration, laboratory results and inpatient/outpatient documents. Cases clinically diagnosed with puerperal infection or receiving antibiotic therapy for infection within 42 days postpartum are coded as "Yes".
Rate of Poor Wound HealingWithin 72 hours after neonatal birth and at day 42 following childbirthPoor wound healing is defined as delayed healing, erythema, exudation, wound dehiscence, infection or requirement for secondary intervention involving episiotomy incision, sutured perineal laceration or cesarean abdominal incision. This indicator is assessed before discharge and at the 42-day postpartum follow-up through outpatient physical examination, medical record review or telephone follow-up, with on-site evaluation by obstetricians arranged when necessary. Cases presenting with marked incision redness and tenderness, purulent discharge, wound dehiscence or delayed healing, or requiring debridement, dressing change and anti-infective treatment are classified as poor wound healing.This rate equals the count of participants with poor postpartum wound healing divided by the total number of delivered participants, multiplied by 100%.
Breastfeeding Status within 42 Days Postpartum42 Days PostpartumData on breastfeeding status within 42 days after delivery are collected from mothers via telephone follow-up, online questionnaires or outpatient revisit interviews, which are categorized into exclusive breastfeeding, mixed feeding, formula feeding and mother-infant separation.

Contacts

CONTACTQianqian Ni, Master of Science, MSc
nqqtmm@163.comCN +86 15005517549

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026