NCT01360060

Brief Summary

Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of magnesium in parturients undergoing Cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

Enrollment Period

3 months

First QC Date

May 17, 2011

Last Update Submit

May 24, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of numeric rating scale (NRS) of postoperative pain during postoperative period

    postoperative 1, 2, 3, and 4 day

Secondary Outcomes (2)

  • incidence of stopping of intravenous PCA during postoperative 4 days

    during postoperative 4 days

  • serum magnesium level of group P

    preoperative 1 h and postoperative 1 day

Study Arms (2)

Group N

parturients who had undergone Cesarean section under the diagnosis of non-preeclampsia

Group P

parturients who had undergone Cesarean section under the diagnosis of preeclampsia

Drug: Magnesium Sulphate

Interventions

Magnesium sulphate was infused for the management of preeclampsia at perioperative period.

Group P

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

medical record review

You may qualify if:

  • parturients undergoing Cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 25, 2011

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 25, 2011

Record last verified: 2011-05

Locations