The objective of this study is to find out is the way contractions are maesurent during labor are of any influence on the lenght and the way women deliver. It also looks if there is any influence on neonatal outcome.
ID
Source
Brief title
Condition
- Maternal complications of labour and delivery
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During of labor:
THe moment of rupturing of the membranes, or the start of dilation with
contractions needs to be noted, the time being meassured starts from first
vaginal examination till the birth of the child.
Interventions during labor:
- augmentation
- Sedation (pethidine)
- Epidural analgesie
- MBO (micro blood resaerch)
Outcome labor:
- Episiotomy
- Artificial births (splits on indications no progress and fetal stress)
- Sectio caesarea
Outcome neonatal:
- Apgar scores after 1, 5 en 10 minuten
- pH and BE from umbilicalcord blood
There will by looked at parae , etnicis and age, after the trial this will be
corrected.
The groups are split in the intra uterine pressure catheter and the external
meassurement. These two will be compared.
From the moment the women is randomized, she stays in the group she started.
Independendly from interventions during the delivery. This means that a part of
the women gets a intra uterine pressure cathter aldo they where primairy not in
that group. This can happen when:
- There is not enough progress
- need for epidural
- suspicion of fetal stress
- inadequate external contractions registration
Secondary outcome
no secondary parameters
Background summary
When there is, during labor the need to have more information about the
contractions the CTG (Cardio-Toco-Graphy) is being used. It registrates the
fetal hartrate and the frequenty and during of contractions. This registration
is extarnal. During labor it's possible to use an internal pressure catheter to
meassure the contractions. This one will also meassure the strenght of the
contractions. The only indications to use a pressure catheter is when there is
a doubt about the strenght of the contraction , the fetal condition, or when
the external registration is not adequate.
In the Netherlands all different hospitals use the pressure catheter with
different guidelines. The Dutch Union of Gynaecology and Obstetrics is only
advising to use the catheter when inducing labor ore while using augmentation.
This is not evidence based. Where complications are known, there is no
reluctance in the use of the catheter.
All studies that have been done, are comparing the use of the pressure catheter
while labor in induced or augmention is used. The studies don't give a
differance in outcome in during of labor, nummer of sectio ceasarion, use of
augmentation and neonatal oucome (Chia 1993, Chua 1994). The thought that an
intra uterine pressure catheter can avoid uterus ruptures is also not evidence
based (Devoe 1992, Rodriquez 1989).
The use of the catheter is not withouth complications. There are different case
reports that tells about infections and perforations af placentae, uterus en
fetal vessels (Handwerker 1985 ,Lind 1999, Nuttall 1978). The percentages are
low, so there are no figures about the risk of the use.
When there is no evidence that the use of something that brings some
complications, there should be looked for evidence to use or not to use..
Study objective
The objective of this study is to find out is the way contractions are
maesurent during labor are of any influence on the lenght and the way women
deliver. It also looks if there is any influence on neonatal outcome.
Study design
A prospective, rondomized trial in the deliveryrooms of the Reinier de Graaf
Gasthuis in Delft, The Netherlands. In each side of the trial there will be 50
women. It's a pilot study.
The trial is during labor. Patients will be screened when entering the delivery
room for the inclusion criteria. The will get the informationletter and asked
to sign if the agree to particepate in the trial. Clinical midwifes and
residents will be in charge of the deliveries.
After the women agreed the will berondomized, and get a pressure catheter, or
not. After that the CTG is being used as always, and the women will get normal
care.
The midwife or resident keeps notes of the vaginal examinations. She writes
down the personal number of the woman, so notes and outcome is easely found in
the omputer.
Study burden and risks
The use of the catheter is not withouth complications. There are different case
reports that tells about infections and perforations af placentae, uterus en
fetal vessels (Handwerker 1985 ,Lind 1999, Nuttall 1978). The percentages are
low, so there are no figures about the risk of the use. The burden is low, it
gives more space to move than the external registration.
The use of external registration of contractions is without any risk
Dr A.M. van der Poellaan 37
2635 LA Den Hoorn (ZH)
Nederland
Dr A.M. van der Poellaan 37
2635 LA Den Hoorn (ZH)
Nederland
Listed location countries
Age
Inclusion criteria
-The women have to be in active labor. (The midwife or resident is the judge of that and has to decide that she's going to deliver)
- spontaneous contractions (There's no primairy induction, and there has to be an expectacion of normal delivery)
- The patient is high risk, but the indication has nothing to do with the progression of labor.
- The patients are Aterme. Between the 37 and 42 weeks
-there has to be a minimal of 2 centimeters dilation (with less dilation it's impossible to place the catheter)
Exclusion criteria
-Take overs from low risk groups with indications:
*dilations with not enough progress (in need of augmentation)
*request epidural
*all indications witch are not during the stage of dilation
- induction af labor
-primairy oxytocin augmention
- Intra uterine infections
-intra uterine fetal death
- breech
- twin pregnancies
- maternal age < 18 years
- Hepatitis B cariers, or HIV infected women
- contra indications for amniotomy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15757.098.07 |