An interventional study of intrapartum ultrasound and vaginal examination in Abnormal Labor and Complication of Delivery, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Health services research
Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.
Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research. All pregnant women intending to have a vaginal delivery were enrolled in the study. After admission, women were randomly assigned to either intrapartum ultrasound (IPUS) or vaginal examination (VE). In IPUS group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. IPUS and VE were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. The progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. Finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 455 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
IPUS group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by intrapartum ultrasound.
Other: intrapartum ultrasound
VE group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by vaginal examination.
Other: vaginal examination
In IPUS group, the patient's labor was observed by intrapartum ultrasound.
In VE group, the patient's labor was observed by vaginal examination.
Duration of the first stage of labor
Medical record about the length of first stage of labor
Time frame: Day 1
Duration of the second stage of labor
Medical record about the length of second stage of labor
Time frame: Day 1
Number of Participants with fever
physiological parameter about the body temperature when the patient has fever
Time frame: Day 3
Number of Participants with the soft birth canal laceration I, II,III, IV
clinical assessment about the soft birth canal laceration after labor, including I(Perineal skin and vaginal entrance mucosa laceration, little bleeding）, II（The lacerated injury has reached the fascia and muscle layer of the perineum, involved the mucous membrane of the posterior wall of the vagina, extended to the groove on both sides of the posterior wall of the vagina and tore upward, the anatomical structure is not easy to identify, and there is more bleeding）,III（The lacerated wound extends deep into the perineum, the external anal sphincter is broken, and the rectal mucosa is intact）, IV（The anus, rectum and vagina are completely penetrated, the rectointestinal cavity is exposed, the histological tissue is seriously damaged）
Time frame: Day 1
Number of Participants with postpartum hemorrhage
total postpartum blood loss in 24 hours measured by weighing method
Time frame: Day 1
Plan to share: No — All data generated or analyzed during this study are available from the Central Contact Person on reasonable request.
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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