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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00488111
Other study ID # NMU-2579FW
Secondary ID NMCH2007-221
Status Completed
Phase N/A
First received June 18, 2007
Last updated August 12, 2008
Start date May 2007
Est. completion date August 2008

Study information

Verified date August 2008
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.


Recruitment information / eligibility

Status Completed
Enrollment 850
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 40 Years
Eligibility Inclusion Criteria:

- 21-40 yr

- First time of delivery

- ASA status I-II

- No premature

- No genetic and infectious diseases

- Chinese

Exclusion Criteria:

- < 21 yr

- > 40 yr

- Subjects with cardiac and pulmonary disorders

- Dislocation of placenta

- Pregnant hypertension

- Allergy to local anesthetics

- Unwilling to cooperation

- Need intraoperative administration of vascular active agents

- With significant delivery side effects

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Ringer's Lactate
Ringer's Lactate was used 15min before operation
6% Starch
6% Starch was used 15min before operation

Locations

Country Name City State
China Nanjing Maternal and Child Care Hospital Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Nanjing Medical University HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total volume of colloid Total volume of crystalloid Total fluid volume 6 months Yes
Secondary Percentage reduction in hematocrit, Days in hospital 6 months Yes
See also
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Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A