Complications; Cesarean SectionPhase 3NCT01665027
Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
A Phase 3 study testing vacuum and routine manual maneuvers for fetal head extraction in people with Complications; Cesarean Section, run by Behnam Baghianimoghadam at 1 site in Iran.
Trial summary
The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- vacuum and routine manual maneuvers for fetal head extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIran
- Study dates
- Dec 2010to Jan 2012
- Phase
- Phase 3
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.
Who cannot join
- Elective cesarean
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid sadoughi University of medical sciences
Yazd, Yazd Province, 8916863411
About this study
The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of delivery by vacuum in C/S with normal caesarean section.
- Conditions
- Complications; Cesarean Section
- Being tested
- vacuum, routine manual maneuvers for fetal head extraction
- Keywords
- caesarean section,, vacuum,, fetal head extraction,, maternal complication,, fetal complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuumProcedure or surgery
Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16).
Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections.
routine manual maneuvers for fetal head extractionProcedure or surgery
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
| Study group | Role | What they receive |
|---|---|---|
| vacuum | Experimental | Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head. He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Receives: Procedure: vacuum |
| routine manual maneuvers for fetal head extraction | Experimental | Procedure/Surgery:
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction Receives: Procedure: routine manual maneuvers for fetal head extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration time between incision and fetal head delivery
In study was done by Arad et al in 1986, duration between incision and end of delivery was significantly lower in vacuum group that (PMID: 3735047). Also in study of Dimitrov et al was done prospectively on 19 caesarean with vacuum and 25 caesarean without it, similar results has been reported (PMID: 18756824).
Measured: during surgery
Secondary outcomes (1)
fetal complications
Mcquinery et al in 2009 in their study concluded that vacuum have less fetal complications (Mc Quivey RW, Laporte V. Vacuum- Assisted Cesarean Section. International Journal of OB/GYN. 2009; S413-S729.). Wen et al in their study concluded that forceps causes more injuries to head and face while cephal hematoma was higher in using vacuum(PMID: 11159152).
Measured: after extraction of fetus and during cleaning of fetus under warmer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Behnam Baghianimoghadam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665027
- Sponsor's protocol ID
- SSU-389049
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
- ClinicalTrials.gov ID
- NCT01665027
- Acronym / sponsor ID
- SSU-389049
- Conditions
- Complications; Cesarean Section
- Keywords
- caesarean section,, vacuum,, fetal head extraction,, maternal complication,, fetal complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Behnam BaghianimoghadamUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Aug 2012 (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 Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of delivery by vacuum in C/S with normal caesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vacuum | Experimental | Procedure: vacuumVacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head. He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). |
| routine manual maneuvers for fetal head extraction | Experimental | Procedure: routine manual maneuvers for fetal head extractionProcedure/Surgery: fetal head techniques like fundal pushing, pulling technique or reverse breech extraction |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.
Key exclusion criteria (1 listed)
- Elective cesarean
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 |
|---|---|---|
| vacuumVacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16). Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections. | Procedure or surgery | vacuum |
| routine manual maneuvers for fetal head extractionfetal head techniques like fundal pushing, pulling technique or reverse breech extraction | Procedure or surgery | routine manual maneuvers for fetal head extraction |
Primary outcome
Mean duration time between incision and fetal head delivery
Time frame: during surgery
In study was done by Arad et al in 1986, duration between incision and end of delivery was significantly lower in vacuum group that (PMID: 3735047). Also in study of Dimitrov et al was done prospectively on 19 caesarean with vacuum and 25 caesarean without it, similar results has been reported (PMID: 18756824).
1 secondary outcome
fetal complications
Time frame: after extraction of fetus and during cleaning of fetus under warmer
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 15 Aug 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vacuum and routine manual maneuvers for fetal head extraction in people with Complications; Cesarean Section, run by Behnam Baghianimoghadam at 1 site in Iran.
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 1 inclusion and 1 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 15 Aug 2012. 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 Iran. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean duration time between incision and fetal head delivery (time frame: during surgery). 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 15 Aug 2012.