Homeopathic Remedy for the Third Stage of Delivery | NCT01156194

Studies
Homeopathic Remedy for the Third Stage of Delivery

NCT01156194

Sponsor

Shaare Zedek Medical Center

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

210Estimated

Phase

Phase 3

Conditions

Third Stage of Labor

Interventions

Homeopathy 1
Homeopathy 2
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jul 1, 2010

First Submission Date that Met QC Criteria

Jul 1, 2010

First Posted Date

Jul 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical CenterPrincipal Investigator

Lead Sponsor

Shaare Zedek Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared with placebo treatment. The purpose of this study is to repeat the previous methodology, this time on a larger population.

210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo (n=70).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Homeopathy 1	Active Comparator	Arnica montana C6 and Bellis perennis C6	Drug: Homeopathy 1
Homeopathy 2	Active Comparator	Arnica montana C30 and Bellis perennis C30	Drug: Homeopathy 2
Placebo	Placebo Comparator	globules identical to true comparators	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Homeopathy 1	Drug	Arnica montana C6 and Bellis perennis C6	Homeopathy 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin levels at 2d postpartum		48h

Secondary Outcomes

Measure	Description	Time Frame
incidence of endometritis		7d
time to extrusion of placenta following birth		24h
duration of lochiae secretion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy women in 3rd stage of labor
age 20-35
second to fifth gestation
spontaneous PV delivery
term delivery (37-42nd weeks)

Exclusion Criteria:

scarred uterus
multifetal pregnancy
history of bleeding problems
caesarian section delivery
chorioamnionitis
pregnancy-induced hypertension
gestational diabetes mellitus
polyhydramnios, premature rupture of membrane
suspected macrosomy/SGA

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternity Ward, Shaare Zedek Medical Center		Jerusalem		91031	Israel

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided