PregnancyPhase 1/2NCT00740350
Logan Basic During Pregnancy on Labor and Childbirth
A Phase 1/2 study testing Logan Basic in people with Pregnancy, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
The purpose of this study is to determine if women who have chiropractic care, according to the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and delivery as compared to women who haven't had chiropractic care during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Logan Basic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Feb 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20-24 weeks pregnant
- enrolled in a separate pre-natal care protocol with an outside provider
- a Logan College Student or member of the family of a Logan Student ("family" as defined by CCE designation)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan University, College of Chiropractic
Chesterfield, Missouri, 63017
About this study
Official title: Does the Logan Basic Protocol for Chiropractic Care During Pregnancy Reduce Labor Time and Increase the Ease of Labor and Childbirth?
The purpose of this study is to determine if women who have chiropractic care, according to the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and delivery as compared to women who haven't had chiropractic care during pregnancy.
Read the detailed description
This study will be designed to test if the Logan Basic Technique system of adjusting pregnant women can reduce labor time and increase the ease of labor and delivery as compared to the labor times reported by Kilpatrick and Laros in the obstetric literature. It is proposed that women who have regular chiropractic care throughout pregnancy or at least for the third trimester will have an easier labor and delivery as well as a shorter labor time than is reported in the literature.
- Conditions
- Pregnancy
- Being tested
- Logan Basic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Logan BasicProcedure or surgery
Logan Basic chiropractic adjustments during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Logan Basic chiropractic adjustments during pregnancy. Receives: Procedure: Logan Basic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post delivery interview/questionnaire
Measured: 2 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startMar 2007
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740350
- Sponsor's protocol ID
- SR0627080139
- Status last verified
- Aug 2008
- First submitted
- 21 Aug 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Logan Basic Protocol for Chiropractic Care During Pregnancy Reduce Labor Time and Increase the Ease of Labor and Childbirth?
- ClinicalTrials.gov ID
- NCT00740350
- Acronym / sponsor ID
- SR0627080139
- Conditions
- Pregnancy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if women who have chiropractic care, according to the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and delivery as compared to women who haven't had chiropractic care during pregnancy.
Detailed description
This study will be designed to test if the Logan Basic Technique system of adjusting pregnant women can reduce labor time and increase the ease of labor and delivery as compared to the labor times reported by Kilpatrick and Laros in the obstetric literature. It is proposed that women who have regular chiropractic care throughout pregnancy or at least for the third trimester will have an easier labor and delivery as well as a shorter labor time than is reported in the literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Logan BasicLogan Basic chiropractic adjustments during pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-24 weeks pregnant
- enrolled in a separate pre-natal care protocol with an outside provider
- a Logan College Student or member of the family of a Logan Student ("family" as defined by CCE designation)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Logan BasicLogan Basic chiropractic adjustments during pregnancy. | Procedure or surgery | Experimental |
Primary outcome
Post delivery interview/questionnaire
Time frame: 2 weeks post delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Logan Basic in people with Pregnancy, run by Logan College of Chiropractic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Montgomery, DC (636-230-2100 ext. 1931, patrick.montgomery@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post delivery interview/questionnaire (time frame: 2 weeks post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.