Mereum Fernando

My first week within the OB/GYN department began at the Maternal Fetal Medicine (MFM) clinic. This clinic is responsible for guiding people through high-risk pregnancies. For example, people with gestational diabetes, high blood pressure or other health issues.

Good Clinical Design:

A common issue with diabetes is tracking blood glucose levels. During pregnancy, it is essential that the pregnant person’s glucose is at a specific, rather narrow, range. In order to safely prescribe insulin or other diabetes medication (metformin), the glucose levels must be recorded and reviewed.  This could mean having to use a finger prick monitor four times a day, which is very inconvenient and uncomfortable. Therefore, people often are advised to use Dexcom, which is an automated glucose sensor that sends information through Bluetooth to the individual’s phone. This also allows providers to review the patient’s blood glucose levels throughout the day. I was able to observe a Dexcom being placed on a patient, and I was surprised by how easy it is to use. The needle component is safely shielded within the plastic packaging, so that it can be disposed of with normal garbage.

Activity: A nurse, specialized in diabetes education, was demonstrating to the patient on how to place and operate the Dexcom.

Environment: This took place within a clinic room.

Interactions: The Dexcom applicator was pushed against the patient’s arm, which triggered a needle to insert the sensor wire. Then, the needle retracts into the plastic shielding of the applicator.
Objects: The Dexcom kit came with an alcohol wipe, paper instructions, and an applicator.
Users: The users within the space were the nurse and the patient.

Bad Clinical Design: 

An example of bad clinical design would be the fetal heart monitors within the MFM clinic. The monitors are placed on a large, 5-wheel, stand that is clunky and are difficult to move from rooms to hallways. Additionally, the baby’s heartbeat that is calculated through the monitor is often incorrect, reporting numbers that are much higher. I observed a doctor state that they usually will use the heart monitor to hear the baby’s heartbeat and then calculate the bpm themselves with a clock to ensure accuracy.

A: Using the fetal doppler to hear the baby’s heartbeat and measure the fetal heart rate.
E: The monitor is used within different clinic rooms. Therefore, it is often dragged in from other rooms through the hallway.
I: The doctor used ultrasound gel on the patient’s stomach and then placed the doppler.
O: I observed the fetal heart monitor which is composed of the doppler and the monitor that reported the calculated heart rate. The monitor is placed on a large base with five caster wheels, similar to an office chair.
U: Within the clinic room, the doctor and medical student were using the doppler.

My second week within the MFM clinic was spent at the Ultrasound department. There is a room dedicated to NST (non-stress testing) to evaluate the fetal heart rate. I was able to observe the sonographers perform different scans such as fetal anatomy, transvaginal scans, doppler, 3-D ultrasound, and fetal echocardiography within the appointment rooms. Each room was equipped with a Samsung HERA W10 Elite Ultrasound machine. These ultrasound machines were each equipped with a Sony printer that allowed the sonographers to print pictures as they scanned. As the sonographers worked, they were able to adjust the frequency of each wand to enhance the contrast of the image. This is ideal for identifying specific veins and arteries because they each have unique waveforms. The depth and detail of the scan are inversely proportional, where there is less detail deeper into the body. Later, I was able to observe the ultrasound attendings and analyze the various scans.

One procedure that I observed was the saline infusion sonogram (SIS) or sonohysterography. This is a procedure that can be done to check for infertility. In order to perform this procedure, a catheter is placed through the vaginal opening and cervix to the uterus. Saline is pushed through the catheter with a syringe into the uterus. This dilates the uterus which can expose any fibroids, polyps, or scarring along the endometrium (inner uterus) lining. Then, a balloon is inflated to prevent the fluid from flowing out of the uterus and air is pushed through the catheter. Throughout this experience, an ultrasound probe is used to visualize the uterus and nearby structures. This allows for the air bubble movement to be analyzed. If a fallopian tube is scarred or closed, there usually will not be air bubble movement seen. This procedure can result in infection, cramping and bleeding of the patient. In cases where there are blocked tubes, the pressure of the saline an air can cause extreme pain in the patient.

According to Opolskiene et al. (2015), postmenopausal women are twice as likely to experience pain during SIS than premenopausal women. Of the 99 women profiled in this study, about 41% (41/99) felt pain [2].

Another procedure that is used in this context is hysterosalpingography (HSG), which is an X-ray dye test. SIS is becoming more common as it is an cheaper, easier, and less painful procedure to understand infertility. Despite all this, HSG is still superior in evaluating the female reproductive tract [1].

[1] Initial fertility evaluation with saline sonography vs. hysterosalpingography: it is debate-tubal. Nguyen, Edward et al. Fertility and Sterility, Volume 121, Issue 6, 922 – 930

[2] Opolskiene, G., Radzvilaite, S., Daiva Bartkeviciene, Ramasauskaite, D., Jolita Zakareviciene, & Grazina Drasutiene. (2015). Pain experience during saline‐contrast sonohysterography differs between premenopausal and postmenopausal women. Journal of Clinical Ultrasound, 44(5), 267–271. https://doi.org/10.1002/jcu.22291

[3] Özkan, S., Kars, B., Sakin, Ö., Onan Yılmaz, A., Bektaş, Y. T., & Kaşıkçı, H. Ö. (2016). The optimal analgesic method in saline infusion sonogram: A comparison of two effective techniques with placebo. Turkish journal of obstetrics and gynecology, 13(3), 132–136. https://doi.org/10.4274/tjod.46667

For the third week of my CIP rotation, I was able to shadow the Labor and Delivery department.

Primary Observation:

A: A patient is in active labor and experiencing contractions. The baby’s position is identified to be face up and head down (occipito-posterior position) by the attending doctor.

E: Hospital room within Labor & Delivery.

I: In order to put the baby in a more ideal position (face down), the doctor uses a manual rotation technique to move the baby into face up position.

O: The hospital bed, fetal heart/contraction monitor

U: Patient, doctors, and nurses

Secondary Observation:

Occipito-posterior (OP) position leads to increased risk, maternal/fetal exhaustion due to the abnormally long labor. This may lead to higher rates of instrumental vaginal delivery, which may include the use of forceps or vacuum. The exhaustion of uterus muscles, uterine atony, can lead to may make it difficult for uterus muscles to contract which could lead to hemorrhage. Therefore, there is a higher risk of an unplanned C-section to prevent risk of hemorrhage. Persistent OP position occurs in around 5-8% of labours [1].

Needs Statement:

Pregnant people at risk of uterine atony from less ideal fetal positions desire methods to increase chance of spontaneous labour without emergency intervention.

Feasibility:

Patent: WO 2018/037298 A1- Uterine Balloon Tamponade (UBT)

Commercial Solutions: Ellavi UBT, Bakri® Postpartum Balloon with Rapid Instillation Components ($629)

Viability:

180,000 – 288,000 people in the USA give birth with OP position, facing increased risk (5-8% of 3.6 mil births)
9% chance of c-section when manual rotation is applied
41% chance of c-section when manual rotation is not used

Total Addressable Market (TAM):
21,060 people * $629 = $13,246,740 (9%)

[1] Guittier, MJ., Othenin-Girard, V., Irion, O. et al. Maternal positioning to correct occipito-posterior fetal position in labour: a randomised controlled trial. BMC Pregnancy Childbirth 14, 83 (2014). https://doi.org/10.1186/1471-2393-14-83

Updated Needs Statement:

Pregnant individuals at risk of uterine atony due to suboptimal fetal positioning seek methods to increase the likelihood of spontaneous labor and reduce the need for emergency intervention.

This needs statement is updated to include all versions of suboptimal fetal positioning, rather than just occipito-posterior position.

IDEO Model:

Desirability: 

It is essential to prevent uterine atony. Risks of this include, increased blood loss, cesareans births, and instrumental births.

Feasibility: 

Currently, solutions are focused on treating uterine atony, rather than preventing. Patients desire a method that is preventative rather than reactive.

Viability:
180,000–288,000 births annually in the U.S. involve OP presentation (5–8% of 3.6 million births)

Cesarean section rates: 9% with manual rotation

41% without intervention

Preventative repositioning could reduce the high C-section rates among these patients.

If a product is priced comparably to postpartum atony devices ($629), a conservative Total Addressable Market (TAM) based on the 9% intervention group:

21,060 individuals × $629 = $13,246,740

Need Statement: People with uteruses who undergo a saline infusion sonogram experience extreme discomfort and pain desire a less uncomfortable while retaining the efficacy of SIS.

1. Equipment Set-up
   • Sonographer sets up the equipment required for SIS, which is a semi-sterile procedure. Tools include saline, syringe, catheter, swabs, and speculum
2. Preliminary Ultrasound
   • Patient arrives to the MFM clinic. They are led to the ultrasound room.
   • The sonographer uses a transvaginal probe to record the baseline images of the uterus and ovaries. The patient is advised that this is a very uncomfortable procedure, and they may need to take breaks.
3. Procedure Begins
   • The doctor arrives to the room and advises the patient on potential complications which include cramping, bleeding, and infection.
   • The doctor inserts the catheter and saline to dilate the uterus. The sonographer inserts the transvaginal probe as well.
4. Patient Experience during Procedure
   • Throughout the procedure, the patient is tense and uncomfortable.
     • Branch A: Patient cannot tolerate procedure, catheter and transvaginal probe is removed. Procedure may be attempted again.
     • Branch B: Patient is able to tolerate procedure

Relevant Medical Codes:

CPT® 76831: Under Diagnostic Ultrasound Procedures of the Pelvis Non-Obstetrical

CPT® 58340: Under Introduction Procedures on the Corpus Uteri