A randomized controlled study of gentle fundal pressure on the second stage of labor and delivery outcomes.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068616

Enrollment

Unknown

Registered

2023-02-24

Start date

2023-07-26

Completion date

Unknown

Last updated

2024-01-14

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

Conditions

Vaginal delivery

Interventions

Intervention group:Gentle fundal pressure

Control group:Routine clinical operation

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 20-35 years old; 2. Gestation between 37+0 and 41+6 weeks; 3. Singleton cephalic presentation; 4. Planned vaginal delivery; 5. Planned receive epidural analgesia; 6. Between 2800g and 4000g of estimated fetal birth weight.

Exclusion criteria

Exclusion criteria: 1. History of previous uterine surgery (cesarean section, myomectomy, hysteroscopy, etc.) or history of bladder or intestinal surgery; 2. Single or multiple fibroids being 5cm or more; 3. Uterine morphology abnormalities (uterine malformation, adenomyosis, etc.); 4. Abdominal wall abnormalities (redness or erythema, etc.); 5. History of alcohol and drug abuse during pregnancy; 6. Abnormal placental position, suspected placental abruption; 7. Abnormal amniotic fluid (excessive /too little), suspected chorioamnionitis, moderate amniotic fluid meconium staining, etc.; 8. Type III fetal heart rate pattern, abnormal uterine activity, fetal growth restriction, fetal abnormality, etc.

Design outcomes

Primary

Measure	Time frame
Long duration of second stage of labor;	—

Secondary

Measure	Time frame
Ues of oxytocin and dosage;Instrumental-assisted;Fundal pressure to fetal head delivery time;Long duration of first stage of labor;Mode of delivery;Episiotomy;Newborn weight;Umbilical artery blood gas analysis;Postpartum hemorrhage;Ruptured uterus;Pain Score;Laceration of the birth canal (cervix, vagina, perineum, and anal sphincter);Hospital stay of the mother;Neonatal Apgar score;Neonatal injury (soft tissue injury, hematoma, fracture, etc.).;Time delivery of fetal head;Time delivery of fetal;Whether the newborn is admitted to the NICU or children's ward.;Hospital stay of the newborn;Neonatal encephalopathy.;Fetal or neonatal death;Neonatal jaundice;	—

Measure

Time frame

Ues of oxytocin and dosage;Instrumental-assisted;Fundal pressure to fetal head delivery time;Long duration of first stage of labor;Mode of delivery;Episiotomy;Newborn weight;Umbilical artery blood gas analysis;Postpartum hemorrhage;Ruptured uterus;Pain Score;Laceration of the birth canal (cervix, vagina, perineum, and anal sphincter);Hospital stay of the mother;Neonatal Apgar score;Neonatal injury (soft tissue injury, hematoma, fracture, etc.).;Time delivery of fetal head;Time delivery of fetal;Whether the newborn is admitted to the NICU or children's ward.;Hospital stay of the newborn;Neonatal encephalopathy.;Fetal or neonatal death;Neonatal jaundice;

—

Countries

China

Contacts

Public ContactHui Du

Fourth Hospital of Shijiazhuang

duhui7040932@163.com+86 136 0321 8359

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026