NCT06254092

Brief Summary

This study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

January 31, 2024

Last Update Submit

February 8, 2024

Conditions

Amniotic Fluid EmbolismPulmonary Hypertension

Keywords

amniotic fluid entering the bloodstreamblood volume of amniotic fluidAmniotic fluid embolism

Outcome Measures

Primary Outcomes (1)

  • sTn

    sTn refers to meconium and mucin extracted from amniotic fluid. The presence of sTn in the patient's serum is a diagnostic method that can directly prove that mucin derived from amniotic fluid has entered the maternal circulation.

    before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward

Secondary Outcomes (5)

  • HR MAP

    before the fetus is delivered,after the fetus is delivered,before the placenta is delivered,after the placenta is delivered,after releasing the tourniquet,before the puerpera is sent back to the ward

  • SPO2,PaO2,PaCO2

    before the fetus is delivered,after the fetus is delivered,before the placenta is delivered,after the placenta is delivered,after releasing the tourniquet,before the puerpera is sent back to the ward

  • Thrombelastogram(TEG)

    before the fetus is delivered,before the puerpera is sent back to the ward

  • Adverse events

    perioperatively

  • Hemorrhage

    before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward

Study Arms (1)

tourniquet

EXPERIMENTAL

The investigators use tourniquets to bind the cervical for intervention groups to block venous return to the lower uterine segments to reduce the inflow of amniotic fluid into the uterus.

Procedure: tourniquet binding of cervical

Interventions

tourniquet binding of cervicalPROCEDURE

The procedure will be performed by surgeons with rich experience in clinical work

tourniquet

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single pregnancy
  • Be in good health, with no high blood pressure or heart disease during pregnancy
  • Without placenta previa and placenta implantation
  • No abdominal adhesions, suitable for operation
  • Signed informed consent by the pregnant woman and her family

You may not qualify if:

  • Serious coagulation abnormality
  • Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation
  • Multiple pregnancies
  • Previous history of abdominal surgery
  • Intraoperative drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiming Zhang

Chenzhou, Hunan, 423000, China

Location

MeSH Terms

Conditions

Embolism, Amniotic FluidHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Pregnancy Complications, CardiovascularPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCardiovascular DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesLung DiseasesRespiratory Tract DiseasesHypertension

Study Officials

  • Zhiming zhang

    Chenzhou NO. 1 people's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingying Zhou

CONTACT

+861861202387zyy172250133@163.com

Yao Chen

CONTACT

+8615115563778chenyao0810@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 12, 2024

Study Start

January 31, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

CN(1)