Clinical trials: Complications; Cesarean Section
Pain, Postoperative
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery.
- Trial name
- NCT02487303
- Testing
- Acetaminophen Intravenous, Acetaminophen Oral
- Where
- United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Twin; Complicating Pregnancy, Postpartum Hemorrhage
Prophylactic Methylergonovine for Twin Cesarean
Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity…
- Trial name
- NCT05772156
- Testing
- Methylergonovine
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Columbia University
Chlorhexidine Gluconate Cloths, Infection; Cesarean Section
STRIPES Study: Study To Reduce Infection Post cEsarean Section
The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis).
- Conditions
- Chlorhexidine Gluconate Cloths, Infection; Cesarean Section, Infectious Morbidity, Surgical Site Infections
- Trial name
- NCT02402907
- Testing
- 2% chlorhexidine gluconate (CHG) cloth
- Where
- United States
- Volunteers
- 1,356 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Surgical Site Infection, Surgical Wound Infection
Antibacterial-coated Sutures at Time of Cesarean
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery.
- Conditions
- Surgical Site Infection, Surgical Wound Infection, Cesarean Section; Infection, Cesarean Section Complications
- Trial name
- ASTC (NCT03386240)
- Testing
- Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures), Vicryl, monocryl, PDS (not coated with triclosan)
- Where
- United States
- Volunteers
- 1,169 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Pregnancy Complications
Carbetocin Myocardium Trial 2014 Part 2
Carbetocin has been in clinical use in EU for some years and the efficacy is documented in several RCTs. Circulatory adverse events leading to death has been reported after intravenous injection of oxytocin.
- Trial name
- CMT2014/2 (NCT03899961)
- Testing
- Oxytocin, Carbetocin
- Where
- 2 sites in Norway
- Volunteers
- 240 people
- Sponsor
- Oslo University Hospital
Cesarean Section, Wound Complications
Cesarean Trial of Staples vs. Sutures
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
- Conditions
- Cesarean Section, Wound Complications, Patient Satisfaction, Pain Measurement
- Trial name
- CROSS (NCT01211600)
- Testing
- Staples, Suture
- Where
- 2 sites in United States
- Volunteers
- 746 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
Pain, Postoperative, Depression, Postpartum
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design.
- Trial name
- NCT05907213
- Testing
- Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2, Ketamine (Ketalar) Dose Level 3
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Placenta Accreta, Postpartum Hemorrhage
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta.
- Conditions
- Placenta Accreta, Postpartum Hemorrhage, Cesarean Section, Tranexamic Acid
- Trial name
- TAPPAS (NCT02806024)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Francisco
Ketamine Adverse Reaction, Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients?
Pain control after cesarean delivery is associated with improved breastfeeding and infant rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine concentrations, which negatively affect every…
- Conditions
- Ketamine Adverse Reaction, Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, Complication of Labor and/or Delivery
- Trial name
- NCT00486902
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- Northwestern University
Opioid-use Disorder, Pain, Postoperative
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD).
- Trial name
- NCT04365465
- Testing
- NSS-2 Bridge, Inactive NSS-2 Bridge, Active control
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Bladder Injury, Complications; Cesarean Section
Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery
Part1:The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions…
- Conditions
- Bladder Injury, Complications; Cesarean Section, Adhesions Pelvic
- Trial name
- NCT04302545
- Testing
- Cystoinflation
- Where
- Pakistan
- Volunteers
- 564 people, healthy volunteers welcome
- Sponsor
- Shazia Saaqib
Postoperative Wound Complications
Negative Pressure Wound Therapy in Cesarean Section
The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients.
- Trial name
- NPWTCS (NCT02289157)
- Testing
- Negative pressure wound therapy
- Where
- United States
- Volunteers
- 441 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Surgical Site Infection
Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis
Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.
- Trial name
- CAPICA (NCT02202577)
- Testing
- Chlorhexidine - Isopropyl alcohol, Povidone-Iodine Scrub and Paint
- Where
- United States
- Volunteers
- 932 people, healthy volunteers welcome
- Sponsor
- Case Western Reserve University
Obstetric Pain, Postpartum Depression
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic…
- Conditions
- Obstetric Pain, Postpartum Depression, Breastfeeding, Pain, Acute
- Trial name
- KINETIC (NCT04037085)
- Testing
- Ketamine
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Analgesia, Obstetrical, Coagulation Defect; Postpartum
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption.
- Conditions
- Analgesia, Obstetrical, Coagulation Defect; Postpartum, Nonsteroidals (NSAIDs)Toxicity, Postpartum Hemorrhage
- Trial name
- KetoPltAgg (NCT03805607)
- Testing
- Ketorolac Tromethamine 30 MG/ML
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Cesarean Section
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples.
- Trial name
- NCT00524511
- Testing
- Surgical skin staples, Dermabond
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- University of Massachusetts, Worcester
Endometritis, Wound Infection
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum…
- Conditions
- Endometritis, Wound Infection, Abscess, Surgical Site Infection
- Trial name
- C/SOAP (NCT01235546)
- Testing
- Azithromycin and standard of care
- Where
- 9 sites in United States
- Volunteers
- 2,013 people
- Sponsor
- Alan Tita
Obesity, Complications; Caesarean Section, Wound
Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
Obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients.
- Trial name
- NCT01528696
- Testing
- Silverlon, Standard Dressing
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Pregnancy, Premature Rupture of Membranes
Cervical Ripening in Premature Rupture of Membranes
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the vaginal canal before the onset of labor.
- Conditions
- Pregnancy, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes, Unfavorable Cervix
- Trial name
- NCT02314728
- Testing
- Misoprostol, Oxytocin
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center