Faculty in the Indiana University School of Medicine Department of Obstetrics and Gynecology are leaders in clinical and laboratory research in many different areas of the field. Researchers in this division perform studies that include genetics and pharmacology, personalized medicine in pregnancy, prevention and treatment of gestational diabetes, prevention of pre-term birth, reversible contraceptive methods, patient-physician communication and shared decision-making and health care delivery. Faculty have won many awards and published numerous studies related to OB-GYN care.
The Department of Obstetrics and Gynecology is actively involved in several clinical trials related to obstetrics and gynecology health care.
Clinical Evaluation of PROMComplete as an Aid in Determination of Rupture of Fetal Membranes PROM
The goal of the PROM study is to determine the clinical performance of PROMComplete relative to the clinical diagnosis for the detection of membrane rupture in a point-of-care setting. Premature rupture of membranes, or PROM, is the rupture of fetal membranes prior to the start of labor. It is associated with a number of neonatal and maternal complications, including an increased incidence of perinatal mortality and intra-amniotic infection. PROMComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.
Exploring Attitudes Perceptions and Coping Responses of Families Facing Threat of Periviable Birth
A periviable birth occurs when the gestational age of the baby is between 20 and 25 weeks. The goal of this study is to assess attitudes, perceptions and coping mechanisms related to death and disability from the perspective of pregnant women, fathers or others when making difficult decisions concerning a periviable delivery. Participants in this study experience pregnancy complications such as rupture of membranes, preterm labor, preeclampsia or growth restriction that pose a potential threat or need for a periviable delivery.
This study is part of the IU Grand Challenges Precision Health Initiative. Pregnant women will be recruited at less than 20 weeks gestation and will be followed throughout their pregnancy looking at risk factors for and development of gestational diabetes. We will also follow the women and their babies up to 2 years after the pregnancy ends. Women will have 2 study visits in pregnancy where they will answer surveys and have blood and samples collected. This will also happen at delivery and postpartum.
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants CUDDLE
The goal of the CUDDLE study is to characterize the pharmacokinetics and safety profile of understudied, off-patent drugs administered to lactating women receiving drugs per standard of care as prescribed by their health care provider. Researchers are recruiting women who are prescribed a drug from a list of 10 commonly used drugs in the postpartum period. The group will be collecting maternal blood and possibly breastmilk, and small amount of infant blood to provide valuable pharmacokinetics, dosing and safety information for drugs in breastfeeding women.
This is a biobanking study in pregnancy where pregnant women are recruited at all stages of pregnancy and asked to provide a blood sample any time they are having blood drawn for clinical reasons. This includes during pregnancy and at the time of delivery, along with infant cord blood at delivery. These samples are processed and stored for future research. So far, the biobank has recruited more than 2,500 women and collected more than 54,000 samples.
Effectiveness of Prolonged Use of IUDImplant for Contraception EPIC
Researchers are working to assess whether contraceptive failure rates of the levonorgestrel intrauterine device (LNG-IUD) in years six to eight of use will be equivalent to failure rates during the first five years of use. They’re also researching if the contraceptive failure rates of the etonogestrel-releasing contraceptive implant in years four to six of use will be equivalent to the failure rates during the first three years of use.
The goal of the FACT study is to determine whether use of an intrauterine device (IUD) impairs fertility. Women participating in this study will complete an interview, physical exam, pelvic exam, blood draw and follow-up interviews every six months.
Levonorgestrel Intrauterine System for Emergency Contraception LIFE
Researchers in this study are evaluating the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) as a method of emergency contraception. They are comparing observed pregnancy rates in those receiving ullipristal acetate and LNG-IUS. Women participating in this study are confirmed to be pregnant, but do not wish to be, and are randomized to either receive an oral emergency contraceptive or the IUD.
Observational Study of Hysteroscopic Sterilization or Laparoscopic Tubal Sterilization POET
Open-Label, Non-Randomized, Prospective Observational Cohort Study to Assess Post-Procedural Outcomes in Two Cohorts of Women who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization (POET)
The primary goal of this study is to evaluate the proportion of participants who experience new onset or worsening chronic lower abdominal and/or pelvic pain and have undergone Essure placement for permanent birth control compared to the proportion of participants who had an attempt at laparoscopic tubal sterilization. Researchers also want to better characterize these reported outcomes and identify pre-procedural and procedure-related characteristics related to their occurrence.
Prospective Study of Immediate Postpartum Contraceptive Decision-Making and Outcomes
Researchers in this study are assessing the decision-making process of patients who express a desire for immediate postpartum contraceptive using DepoProvera, Nexplanon and progestin IUD. Participants fill out surveys to assess the rate of continued breastfeeding and short interval pregnancy.