Tramadol for Labour Analgesia in Low Risk Primiparous Women | NCT01889979

Studies
Tramadol for Labour Analgesia in Low Risk Primiparous Women

NCT01889979

Sponsor

Saint Thomas Hospital, Panama

Status

Completed

Last Update Posted

Jul 9, 2013Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Pain During Labour

Interventions

Tramadol
Placebo

Countries

Panama

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

Jul 2013

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

Oct 2012

Primary Completion Date

May 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jun 28, 2013

First Posted Date

Jul 1, 2013Estimated

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

Jul 7, 2013

Last Update Posted Date

Jul 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, PanamaPrincipal Investigator

Lead Sponsor

Saint Thomas Hospital, PanamaOTHER

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

Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tramadol	Experimental	100 mg of tramadol SC (single dose) = 2 mL	Drug: Tramadol
Placebo	Placebo Comparator	2 mL of a sterile solution SC	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tramadol	Drug	100 mg of Tramadol was applied in the forearm SC (single dose).	Tramadol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain during labour	Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).	6 hours

Secondary Outcomes

Measure	Description	Time Frame
Duration of labour	The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.	12 hours
Neonatal outcomes	Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age between 37 and 40 6/7 weeks
Primiparous patient
Singleton
4 to 5 cms of dilation
Intact membranes or spontaneous rupture of membranes less than 2 hours
Fetus in a vertex presentation
Gynecoid pelvis by clinical examination

Exclusion Criteria:

Multiparous
Multiple pregnancies
Any pathology
Induction of labour with prostaglandins

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osvaldo Reyes, MD	Saint Thomas Maternity Hospital	Principal Investigator
Riggie Castillo, MD	Saint Thomas Maternity Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Thomas Maternity Hospital		Panama City		1439 zona 9A	Panama

Intervention Browse Module

MeSH Terms

ID	Term
D014147	Tramadol

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

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Browse Branches

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