Labour PainNCT02697994
Sterile Water Injections For Pain Relief İn Labor
A study testing Sterile Water and Dry Injections in people with Labour Pain and Back Pain, run by University of Beykent.
Trial summary
ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Labour Pain, Back Pain
- What is being tested?
- Sterile Water and Dry Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-35
- 37-42 weeks of gestation
- Expecting vaginal delivery
- Cephalic presentation
- Single, healthy fetus
- Spontaneous onset of labor
Show all 9Show fewer
- Active phase of first stage of labor (3-7 cm cervical dilatation)
- Severe low back pain (VAS>7cm)
- Required pain relief
Who cannot join
- Gestation <37 weeks
- Multiple pregnancy
- Malpresentation
- Second stage labour
- Pharmacological analgesia prior to SWI
- Back pain assessed by VAS <7
- Women whose labour would be considered high risk
About this study
Official title: Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial
ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.
Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.
- Conditions
- Labour Pain, Back Pain
- Being tested
- Sterile Water, Dry Injections
- Keywords
- Sterile Water Injection, Midwifery
- Medical subject headings
- Labor Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile WaterOther
0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.
Dry InjectionsOther
dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.
| Study group | Role | What they receive |
|---|---|---|
| Sterile Water Injection | Experimental | Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area. Receives: Other: Sterile Water |
| Dry Injection | Placebo comparator | Participants in the control group received 4 dry injections in the same region using an insulin needle . Receives: Other: Dry Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores-30
In pain scoring Visual Analog Scale was used
Measured: at 30 mins after interventions
Secondary outcomes (9)
Pain scores-10
In pain scoring Visual Analog Scale was used
Measured: at 10 mins after interventions
Pain scores-60
In pain scoring Visual Analog Scale was used
Measured: at 60 mins after interventions
Pain scores-90
In pain scoring Visual Analog Scale was used
Measured: at 90 mins after interventions
Pain scores-120
In pain scoring Visual Analog Scale was used
Measured: at 120 mins after interventions
Pain scores-180
In pain scoring Visual Analog Scale was used
Measured: at 180 mins after interventions
APGAR score of neonate
Measured: at 5 mins after birth
Maternal satisfaction
Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others
Measured: at 1 hour after birth
Rates of breastfeeding-1
In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
Measured: at 1 hour after birth
Rates of breastfeeding-24
In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
Measured: at 24.hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, refika genç koyucu, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697994
- Sponsor's protocol ID
- SWI1315
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02697994
- Acronym / sponsor ID
- SWI1315
- Conditions
- Labour Pain, Back Pain
- Keywords
- Sterile Water Injection, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Mar 2016 (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.
ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.
Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile Water Injection | Experimental | Other: Sterile WaterParticipants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area. |
| Dry Injection | Placebo comparator | Other: Dry InjectionsParticipants in the control group received 4 dry injections in the same region using an insulin needle . |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged between 18-35
- 37-42 weeks of gestation
- Expecting vaginal delivery
- Cephalic presentation
- Single, healthy fetus
Key exclusion criteria (7 listed)
- Gestation <37 weeks
- Multiple pregnancy
- Malpresentation
- Second stage labour
- Pharmacological analgesia prior to SWI
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 |
|---|---|---|
| Sterile Water0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area. | Other | Sterile Water Injection |
| Dry Injectionsdry injections into the skin surrounding the Michaelis rhomboid over the sacral area. | Other | Dry Injection |
Primary outcome
Pain scores-30
Time frame: at 30 mins after interventions
In pain scoring Visual Analog Scale was used
9 secondary outcomes
Pain scores-10
Time frame: at 10 mins after interventions
Pain scores-60
Time frame: at 60 mins after interventions
Pain scores-90
Time frame: at 90 mins after interventions
Pain scores-120
Time frame: at 120 mins after interventions
Pain scores-180
Time frame: at 180 mins after interventions
APGAR score of neonate
Time frame: at 5 mins after birth
Maternal satisfaction
Time frame: at 1 hour after birth
Rates of breastfeeding-1
Time frame: at 1 hour after birth
Rates of breastfeeding-24
Time frame: at 24.hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Water and Dry Injections in people with Labour Pain and Back Pain, run by University of Beykent.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores-30 (time frame: at 30 mins after interventions). 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 3 Mar 2016.