Adhesion Formation After Primary Cesarean DeliveryPhase 3SPARCNCT00697606
Seprafilm® for Prevention of Adhesions at Repeat Cesarean
A Phase 3 study testing Seprafilm® in people with Adhesion Formation After Primary Cesarean Delivery, run by Abington Memorial Hospital at 1 site in United States.
Trial summary
Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Adhesion Formation After Primary Cesarean Delivery
- What is being tested?
- Seprafilm®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2011
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women after 24 weeks' gestation.
- First cesarean delivery.
- Age > 18 years.
- Cesarean to be performed by a participating surgeon.
- Non-closure of the visceral or parietal peritoneum.
Who cannot join
- Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.
- Clinical diagnosis of chorioamnionitis.
- Women having tubal ligation at the time of primary cesarean.
- Inability to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abington Memorial Hospital
Abington, Pennsylvania, 19001
About this study
Official title: Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section
Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.
Read the detailed description
This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment.
Participants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.
- Being tested
- Seprafilm®, Control
- Keywords
- Seprafilm®, cesarean, adhesions, primary, repeat
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seprafilm®Device
Seprafilm® placed at time of primary cesarean
ControlOther
no Seprafilm® used at primary cesarean
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Seprafilm® Receives: Device: Seprafilm® |
| B | Sham comparator | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.
Measured: at repeat cesarean
Secondary outcomes (4)
To determine to what extent Seprafilm® decreases the incidence of adhesion formation.
Measured: at repeat cesarean
To determine the incidence of adhesion formation during repeat cesarean delivery.
Measured: at repeat cesarean
To evaluate complication rates in those with Seprafilm® versus those without during repeat surgery by examining length of operating times, blood loss, bladder injuries, and Apgar scores
Measured: at repeat cesarean
To determine the incidence of fertility issues in women having Seprafilm® placed during primary cesarean delivery versus those not having Seprafilm® placed. Participating women will be contacted by telephone every 4 months.
Measured: ongoing during trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesion Formation After Primary Cesarean DeliveryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peleg, MD, Abington Memorial Hospital
- Investigators
- Amy Mackey, MD, Principal investigator, Abington Memorial HospitalMark Shahin, MD, Principal investigator, Abington Memorial HospitalRichard Latta, MD, Principal investigator, Abington Memorial HospitalDavid Peleg, MD, Principal investigator, Abington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697606
- Sponsor's protocol ID
- Study #08-032
- Acronym
- SPARC
- Status last verified
- Dec 2015
- First submitted
- 12 Jun 2008
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section
- ClinicalTrials.gov ID
- NCT00697606
- Acronym / sponsor ID
- SPARC / Study #08-032
- Keywords
- Seprafilm®, cesarean, adhesions, primary, repeat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Jun 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.
Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.
Detailed description
This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment.
Participants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Seprafilm®Seprafilm® |
| B | Sham comparator | Other: ControlControl |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women after 24 weeks' gestation.
- First cesarean delivery.
- Age > 18 years.
- Cesarean to be performed by a participating surgeon.
- Non-closure of the visceral or parietal peritoneum.
Key exclusion criteria (4 listed)
- Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.
- Clinical diagnosis of chorioamnionitis.
- Women having tubal ligation at the time of primary cesarean.
- Inability to obtain informed consent.
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 |
|---|---|---|
| Seprafilm®Seprafilm® placed at time of primary cesarean | Device | A |
| Controlno Seprafilm® used at primary cesarean | Other | B |
Primary outcome
To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.
Time frame: at repeat cesarean
4 secondary outcomes
To determine to what extent Seprafilm® decreases the incidence of adhesion formation.
Time frame: at repeat cesarean
To determine the incidence of adhesion formation during repeat cesarean delivery.
Time frame: at repeat cesarean
To evaluate complication rates in those with Seprafilm® versus those without during repeat surgery by examining length of operating times, blood loss, bladder injuries, and Apgar scores
Time frame: at repeat cesarean
To determine the incidence of fertility issues in women having Seprafilm® placed during primary cesarean delivery versus those not having Seprafilm® placed. Participating women will be contacted by telephone every 4 months.
Time frame: ongoing during trial
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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.
Amy Mackey, MD principal investigator
Abington Memorial Hospital
Mark Shahin, MD principal investigator
Abington Memorial Hospital
Richard Latta, MD principal investigator
Abington Memorial Hospital
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 Seprafilm® in people with Adhesion Formation After Primary Cesarean Delivery, run by Abington Memorial Hospital 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 Dec 2015. 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. 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.
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 was stopped early (reason given: lack of funding). Results are not available in the source record.
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?
To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean. (time frame: at repeat cesarean). 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 30 Dec 2015.