# A Phase 2 clinical study of the Materna device to shorten delivery time during childbirth

> **NIH NIH R44** · MATERNA MEDICAL · 2020 · $1,071,147

## Abstract

Vaginal delivery involves a high risk of pelvic injury damage that can lead to lifelong pelvic floor disorders for
mothers, and can be a stressful event for babies where long delivery times, instrumented deliveries, and C-
sections are the result of difficult deliveries. Both maternal injuries and longer delivery times are challenged
that are posed by the same biomechanical phenomenon of pelvic tissue resistance during childbirth. Currently,
there are no dilation protocols or devices that can shorten delivery and prevent pelvic tissue injuries. There is
an urgent unmet clinical need to ease delivery and prevent injuries that may arise from childbirth.
The Materna Device is a mechanical birth dilator that pre-stretches pelvic muscles over ~1 hour during the first
phase of labor, thus easing delivery by reducing tissue resistance. It was used safely as designed during the
second active phase of labor in 38 subjects. No injuries, lacerations, vaginal tearing, or adverse events
occurred due to its usage. In this SBIR Fast-Track application, we plan to (i) optimize dilation protocol as to
time and duration of placement of the Device; (ii) reduce delivery time by 20%; and (iii) lower the risk of pelvic
tissue injury from 33% of all births to less than 20%. This Project is based on a proven collaboration between
Materna Medical (device functionality and safety features), Baylor College of Medicine (clinical study and data)
and the Pelvic Floor Research Group at the University of Michigan (modeling of tissue biomechanics).
Our Specific Aims are to: 1) Determine the optimal clinical protocol for the Materna Device using computer
simulations. Computer models will be updated to optimize the dilation protocol for the Device using
biomechanical data from the prior clinical Phase I study. 2) Finalize Materna Device design; build and produce
Devices for the study. The Phase II study Device design is essentially complete; here we will bench test the
design, and update its data collection system. 3) Submit and receive approval of Clinical Protocol. Once the
required Device modifications that provide the optimal dilation protocol have been determined, the Clinical
Protocol will be finalized and submitted for IRB approval. 4) Demonstrate in a randomized controlled trial
conducted at a single site (n=100), that pre-dilation by the Materna Device of the vaginal canal and pelvic floor
muscles to 8 cm during the first stage of labor could shorten the second stage of labor and lead to fewer
pubovisceral muscle tears and avulsions. This Phase II study is designed to provide the data required to
submit the Materna Device for FDA clearance. 5) Utilize computer simulations to develop predictive
parameters to identify women at-risk for sequelae following vaginal delivery. Here, we will use patient data
from Aim 4 to update our biomechanical model so it will better predict birth canal behavior during delivery.
If successful, we believe the Materna Device may become part of a ...

## Key facts

- **NIH application ID:** 9987670
- **Project number:** 5R44HD096987-03
- **Recipient organization:** MATERNA MEDICAL
- **Principal Investigator:** Kelly Ashfield
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,071,147
- **Award type:** 5
- **Project period:** 2019-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9987670

## Citation

> US National Institutes of Health, RePORTER application 9987670, A Phase 2 clinical study of the Materna device to shorten delivery time during childbirth (5R44HD096987-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9987670. Licensed CC0.

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