Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Chicago
1. Visit 1: the screening, consent and randomization visit. This takes place in the Family Birth Center as described above. The patient is approached for consent, randomized, and receives the study intervention in the postpartum period. Randomization will be performed through REDCap using permuted block technique. A permuted block randomization procedure will be used to formulate assignment lists in order to assure close to equal numbers of subjects in each treatment group. A uniform block size of 4 will be used, and the allocation ratio within each unit will be 1. A list of random digits (0-9) will be generated by a computer based random number generator. The list will then be transformed into a randomization schedule. Using a block size of four subjects, with four potential treatment groups, a permutation block assignment list will be created. Because of the block size, an allocation ratio of 1 will be assured after each subsequent group of eight subjects is allocated. Randomization will be performed using a computer-generated sequence in two blocks. Sequentially numbered opaque envelopes displaying only the randomization number on the outside will then be used. These envelopes will be stored in a locked closet on the labor and delivery unit. Blinding: Given the nature of the study, neither patients nor the covering provider can be blinded. Prior to discharge, patients receive the WOMB postnatal satisfaction questionnaire (WOMBPNSQ) and this is all considered the same visit (the labor and delivery visit). 2. Visit 2: this refers to the Postpartum visit. At anywhere from 2 to 12 weeks postpartum, the patient will come to see their provider for follow up care. At this visit, it is standard of care to collect the EDPS depression survey. This score will be collected for study data from the electronic medical record. Patients will be approached if they have a diagnosis of preeclampsia with severe features. Patients who consent to participate in the study and are eligible will be randomized into 24 hours of magnesium therapy or 12 hours of magnesium therapy in the postpartum period. Magnesium levels will be obtained if indicated by standard protocol by patient symptoms and will be defined as magnesium level greater than 8.4 mg/dL or symptoms such as hyporeflexia, pulmonary edema, altered mental status. Patients will be asked to complete two surveys in the postpartum period, one for depression scoring and one for patient satisfaction in the postpartum period. The patient satisfaction survey will be administered prior to discharge from the hospital postpartum. The depression score survey will be administered at the patient's postpartum visit, as is the standard of care at all postpartum visits regardless of medical diagnoses. Progression of symptoms/presence of symptoms is something that is subjectively measured by the physician team when rounding on the patient, by the nurses when assessing the patient, and is clearly documented in progress notes throughout the day and the patient's inpatient admission. Blood pressures are documented in the chart at regular intervals when they are recorded on the floor, and are easily accessed in the Vitals section of the EMR. The investigators outcome measure is not "improved" breastfeeding, but breastfeeding as a binomial variable (yes/no) and this is also clearly documented in the chart in progress note from the physician team, nursing team, and lactation team. This measure is regularly recorded within the investigators department for data collection for the entire Family Birthing Center. I have previously deleted maternal-neonatal bonding as an outcome measure, this is no longer a measure in investigators study. Magnesium toxicity is first suspected clinically and would be documented in the progress note section of the EMR, and it is confirmed with serum measurement of magnesium level (\>8.4). This is documented in the Results Review/Laboratory section of the EMR and is easily accessible in the chart. Patient/maternal satisfaction with birth experience and postnatal experience will be evaluated by the WOMBPNSQ survey and postpartum depression will be evaluated by the Edinburgh survey. Foley catheter removal is documented by nursing in the intake/output section of the medical record. Time to ambulation will be extrapolated by rounding notes from the care team. Continuation/discontinuation rules: if the patient is randomized to the 12 hour magnesium arm and has worsening labs, uncontrollable blood pressures, or worsening headache/neurologic symptoms, they are deemed at a higher risk of eclamptic seizure and will therefore receive a full 24 hours of magnesium as is the standard of medical care. They will remain enrolled in the study, not be withdrawn, and be analyzed by intention to treat as they were randomized to the 12 hour arm. If the patient is randomized to the 24 hour arm, they will continue until 24 hours unless they have signs/symptoms of magnesium toxicity or if they self-withdraw from the study arm. Length of study: For the individual patient, involvement in the study will last from enrollment until the postpartum appointment, which may be as far out as 10-12 weeks postpartum. Access to the patient's chart and information for the purposes of data extraction and analysis and completion of the study, manuscript preparation and submission, will last up to 3 years. The investigators will continue to store this information for 3 years before destroying all data collected.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
