Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04159857 |
| Other study ID # |
IRB 028-18 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2020 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
March 2022 |
| Source |
The Reading Hospital and Medical Center |
| Contact |
Xuezhi (Daniel) Jiang, MD |
| Phone |
4846288981 |
| Email |
daniel.jiang[@]towerhealth.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to assess the efficacy and safety of an innovative two-hand (hand
forceps) fetal head extraction technique during the transverse cesarean sections (LTCS) by
comparing with the conventional one-hand technique used worldwide for centuries.
The primary research question of the study is whether two-hand fetal head extraction
technique results in quicker head delivery. The secondary research question is whether
two-hand technique would cause increased incidence of extension of uterine incision as well
as other adverse events while compared to conventional one-hand technique.
Our hypothesis is that two-hand technique would speed up fetal head delivery without
increasing the risk of extension of uterine incision as well as other adverse events, in the
meantime, maternal discomfort will be significantly reduced since fundal pressure will not be
required during the fetal head delivery.
Description:
It is not unusual that obstetricians struggle with head delivery during the LTCS, when it
occurs, it can not only lead to substantial personal distress for the individual surgeons,
but also frequently require operative delivery (vacuum or forceps), deliberate extension of
hysterotomy (i.e. inverted T-incision on the uterus), or partial transection of rectus
muscles which may be associated with higher maternal and neonatal morbidity as well as
obstetrical and surgical complications for the future pregnancy.
During LTCS, the fetal head traditionally is delivered by one-hand manual extraction (a
surgeon inserts one hand into the uterus via the hysterotomy and lifts the fetal head out of
maternal pelvis, subsequently significant abdominal pressure is required to squeeze the fetal
head out of hysterotomy) along with application of significant abdominal/fundal pressure.
While abdominal pressure may cause maternal discomfort, in some cases (i.e. obesity with big
pannus or thickened anterior abdominal wall, high-floating/mobile fetal head above the
hysterotomy incision, tight rectus muscles, tight U- or V-shaped transverse hysterotomy
incisions, deflexed fetal head), application of vacuum or obstetrics forceps, deliberate
extension of hysterotomy incision either transversely or vertically (inverted t-incision),
excessive uterine fundal pressure or partially transection of rectus abdominis muscles may be
required. In addition to maternal discomfort due to increased fundal pressure, the result
often is either traumatic or undue delay in delivering the infant. An innovative approach to
manual head extraction, with surgeon's both hands formed as a pair of forceps, has been used
by the PI of this study for years during the LTCS for head extraction in the difficult
situations described above without complication, often time it was used after one hand
approach failed to deliver the infant, vacuum/forceps and abdominal pressure has never been
needed in these cases. One potential argument against two-hand technique is that it could
increase the risk of extension of uterine incision since two hands require more intrauterine
space than one hand. This was never the case based on PI's personal experience, however, no
evidence-based data is available to support or recommend against the clinic use of this
two-hand approach. This study was designed to compare the efficacy and safety outcome of two
different head extraction techniques in a randomized controlled study. If two-hand approach
was approved to be a safe and more effective way for fetal head extraction during LTCS, it
would potentially reduce the likelihood of application of vacuum/forceps and deliberate
extension of hysterotomy (i.e. Inverted T-incision which may disqualify the patient for trial
of labor after C-section [TOLAC] for the future pregnancy since the risk of uterine rupture
may be significantly increased after t-incision was made in the previous pregnancy), in
addition to significant mental stress reduction for surgical team and relief of maternal
discomfort caused by excessive fundal pressure.
This study consists of two phases with phase 1 being a prospective case series study for
safety data collection, and phase 2 being a randomized control study that includes two study
groups (two-hand vs. one-hand).
Phase 1: all OBGYN residents will be trained to learn and grasp the two-hand technique via
watching educational videos and practicing in simulation lab. The technique includes two key
steps. Step 1, insert one hand into the hysterotomy to assess position of fetal head with
vast majority of cases being occiput transverse, then insert the second hand to form a
hand-forceps to cover both ears and lower jawbones on the side. Surgeon's fingers need to
pass mandibles to secure sufficient grip to prevent slipping. Step 2, pulling fetal head out
of hysterectomy, Step 3, delivering posterior shoulder followed by anterior shoulder once
fetal head was delivered. Residents must be signed off by PI based on above criteria prior to
administering the two-hand technique in real patients. Residents will be allowed to apply
two-hand technique when they encounter difficulty delivering fetal head by one-hand technique
and prior to applying vacuum or forceps assisted delivery or extending the hysterotomy
(inverted T incision). Phase 1 will primarily focus on safety assessment of two-hand
technique, therefore, data on extension of uterine incision and neonatal outcome will be
collected. Consent will not be required for the phase 1 since hand-forceps technique will
only be used after conventional one-hand technique failed and before more invasive vacuum or
metal forceps is applied. If increase in negative neonatal outcome is not noted and none of
negative outcomes was considered being associated with two-handed technique, after 30 cases
were assessed, investigators will move on to phase 2 after informing RAC and IRB. Incidence
of spontaneous extension of uterine incision will not be considered primary end point for the
phase 1 since extension can be attributed to many factors (i.e. thin lower uterine segment
due to prolonged labors, bending the hand while lifting fetal head out of lower pelvis, etc.)
rather than the two-hand technique, and it will be unlikely to distinguish the real cause of
extension in phase 1 without doing a head-to-head comparison. The incidence of one handed
technique leading to extended hysterotomy (background incidence) is unknown thus it will be
unrealistic to compare the incidence of extension of hysterotomy observed in phase 1 with
background incidence either.
Phase 2: After informed consent was obtained either in the women's health center (WHC) or
labor & delivery (L&D), study subjects will be recruited for undergoing an elective cesarean
section. Inclusion criteria include gestational age 37 weeks or above with cephalic
presentation, planned low transverse uterine incision, cervical dilation <= 6cm, station < 0.
All recruited subjects will be randomized to the study or control arm in L&D according to a
computer generated randomized schedule. Group assignment will be concealed in an envelope
labeled with subject number and opened prior to C-section. All deliveries will be timed by a
designated staff using stopwatches from the time of entry into the uterus (insertion of a
surgeon's hand into uterus through the fully transected lower uterine segment) until the full
delivery of the fetal head. Cesarean section will be timed by OR staff as a matter of
routine. Although it may be easy to learn and grasp the skill of two-hand technique, all
house staffs must be trained to use both hands for head extraction in phase 1. If delivery
was not imminent after attempting at manual extraction with one-hand technique in control
group, then the surgeon should proceed with two-hand technique prior to extending the
hysterotomy incision and/or applying vacuum or forceps, and vice versa. The study will be
registered with clinicaltrials.gov. The number of patients approached for study, met
criteria, recruited, and withdrawal will be tracked and recorded. Both intention-to-treat and
per-protocol analyses will be conducted. Aside from an electronic medical record (EPIC),
additional information will be recorded in a separate datasheet such as time from entry of
uterus to delivery of fetal head (U-D interval), whether excessive fundal pressure was
applied (defined as a pressure that was applied by both surgeons or one of surgeons standing
with both feet in a tiptoe position and keeping both arms and elbows straight so that
shoulders are directly over surgeon's hands), whether initial planned technique fails and the
alternative technique succeeds, any laceration or extension of hysterotomy incision (whether
C-section is elective or not, cervical dilatation and station prior to C-section, thickness
of subcutaneous tissue (>6 cm or <=6 cm), head engaged or high floating, direction
[horizontal, vertical, oblique] and location[apex of hysterotomy incision, inferior aspect of
hysterotomy incision, cervical laceration]) of extension, whether deliberate extension of
hysterotomy incision was made and location(lateral extension, inverted T-incision), whether
vacuum or forceps was applied. Time from entry of uterus and fetal head delivery as a primary
outcome as well as other continuous variables with normal distribution, such as age, maternal
weight and BMI, will be analyzed using student's t-test. Non-parametric methods will be
applied to ordinal data or non-normally distributed continuous data. Categorical variables
(i.e. success rate of initial attempt at per-protocol extraction technique) will be analyzed
using Chi-square test. SPSS or SAS will be used for statistical analysis. P<0.05 is deemed
statistically significant.
Mean U-D intervals using one-hand technique for manual extraction range from 30-60 seconds in
the literature (1-5). Investigators used 45+/-15 seconds as a mean U-D interval, one sided
test, α level of 0.05, 80 % power to detect 30% reduction in U-D interval, a total sample
size of 42 (21 for each group) will be needed. If 20% of study withdrawal was taken into
account, a total of 52 patients need to be recruited.
